Trial Outcomes & Findings for An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels (NCT NCT04195594)

NCT ID: NCT04195594

Last Updated: 2021-05-04

Results Overview

The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: 70 days
• Results posted on: 2021-05-04

Participant Flow

Participant milestones

Measure	Nic's Keto Diet Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Study STARTED	14
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels

Baseline characteristics by cohort

Measure	Nic's Keto Diet n=14 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.86 years STANDARD_DEVIATION 7.36 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Eastern European White	4 Participants n=5 Participants
Race/Ethnicity, Customized South American	3 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Western European White	6 Participants n=5 Participants
Region of Enrollment Canada	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 70 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet	-2.25 percentage of body fat Standard Deviation 2.48

PRIMARY outcome

Timeframe: 70 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet	2.24 percentage of muscle mass Standard Deviation 2.49

PRIMARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet	-4.41 percentage of body fat Standard Deviation 4.04

PRIMARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet	4.38 percentage of muscle mass Standard Deviation 4.03

PRIMARY outcome

Timeframe: 70 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to weight as assessed by BMI was reported at baseline and compared to day 70.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet	-1.64 kg/m^2 Standard Deviation 0.83

PRIMARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to weight as assessed by BMI was reported at baseline and compared to day 140.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet	-2.82 kg/m^2 Standard Deviation 1.49

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days	0.36 mm/hr Standard Deviation 4.43

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days	-0.71 mg/L Standard Deviation 2.10

SECONDARY outcome

Timeframe: 28 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet	-3.02 kg Standard Deviation 2.09

SECONDARY outcome

Timeframe: 56 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet	-4.47 kg Standard Deviation 2.79

SECONDARY outcome

Timeframe: 84 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet	-5.58 kg Standard Deviation 3.07

SECONDARY outcome

Timeframe: 112 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet	-6.43 kg Standard Deviation 3.93

SECONDARY outcome

Timeframe: 28 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet	1.23 mm Hg Standard Deviation 7.79

SECONDARY outcome

Timeframe: 56 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet	-3.06 mm Hg Standard Deviation 6.62

SECONDARY outcome

Timeframe: 84 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet	-2.73 mm Hg Standard Deviation 8.30

SECONDARY outcome

Timeframe: 112 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet	-3.85 mm Hg Standard Deviation 7.58

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet	-6.52 mm Hg Standard Deviation 9.53

SECONDARY outcome

Timeframe: 28 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L)

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet	0.87 mmol/L Standard Deviation 1.01

SECONDARY outcome

Timeframe: 28 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet	0.04 mmol/L Standard Deviation 0.62

SECONDARY outcome

Timeframe: 28 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet	-0.04 mmol/L Standard Deviation 0.27

SECONDARY outcome

Timeframe: 28 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet	0.89 mmol/L Standard Deviation 0.84

SECONDARY outcome

Timeframe: 56 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet	0.91 mmol/L Standard Deviation 0.97

SECONDARY outcome

Timeframe: 56 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet	-0.07 mmol/L Standard Deviation 0.67

SECONDARY outcome

Timeframe: 56 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet	0.01 mmol/L Standard Deviation 0.28

SECONDARY outcome

Timeframe: 56 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet	0.93 mmol/L Standard Deviation 0.87

SECONDARY outcome

Timeframe: 84 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet	1.13 mmol/L Standard Deviation 1.21

SECONDARY outcome

Timeframe: 84 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet	-0.11 mmol/L Standard Deviation 0.57

SECONDARY outcome

Timeframe: 84 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet	0.02 mmol/L Standard Deviation 0.32

SECONDARY outcome

Timeframe: 84 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet	1.16 mmol/L Standard Deviation 1.12

SECONDARY outcome

Timeframe: 112 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet	1.01 mmol/L Standard Deviation 1.31

SECONDARY outcome

Timeframe: 112 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet	-0.16 mmol/L Standard Deviation 0.55

SECONDARY outcome

Timeframe: 112 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet	0.10 mmol/L Standard Deviation 0.38

SECONDARY outcome

Timeframe: 112 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet	0.99 mmol/L Standard Deviation 1.17

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet	1.06 mmol/L Standard Deviation 1.10

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet	-0.23 mmol/L Standard Deviation 0.41

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet	0.15 mmol/L Standard Deviation 0.27

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet	1.02 mmol/L Standard Deviation 0.94

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet	-0.22 percent of Glycosylated Haemoglobin Standard Deviation 0.18

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet	-0.06 mmol/L Standard Deviation 0.37

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet	-0.85 pmol/L Standard Deviation 0.55

SECONDARY outcome

Timeframe: 70 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet	-4.90 kg Standard Deviation 2.66

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet	-8.55 kg Standard Deviation 4.74

SECONDARY outcome

Timeframe: 70 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet	-3.72 mm Hg Standard Deviation 7.96

SECONDARY outcome

Timeframe: 28 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet	3.23 mm Hg Standard Deviation 6.06

SECONDARY outcome

Timeframe: 56 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet	0.44 mm Hg Standard Deviation 5.13

SECONDARY outcome

Timeframe: 70 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=12 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet	-0.14 mm Hg Standard Deviation 6.81

SECONDARY outcome

Timeframe: 84 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet	-2.33 mm Hg Standard Deviation 7.34

SECONDARY outcome

Timeframe: 112 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet	-1.21 mm Hg Standard Deviation 5.25

SECONDARY outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet	0.30 mm Hg Standard Deviation 6.60

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: Safety population

Number of pre-emergent and post-emergent adverse events (AEs)

Outcome measures

Measure	Nic's Keto Diet n=14 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Number of Pre-emergent and Post-emergent Adverse Events	44 events

OTHER_PRE_SPECIFIED outcome

Timeframe: 70 days

Population: Safety population

ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.

Outcome measures

Measure	Nic's Keto Diet n=14 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: Safety population

ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.

Outcome measures

Measure	Nic's Keto Diet n=14 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Heart Rate After 140 Days of Following Nic's Keto Diet	0.61 bpm Standard Deviation 9.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=11 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet	-2.82 kg/m^2 Standard Deviation 1.49

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet	-1.01 U/L Standard Deviation 7.82

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet	0.08 U/L Standard Deviation 6.95

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet	0.23 µmol/L Standard Deviation 5.63

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Creatinine After 140 Days of Following Nic's Keto Diet	3.77 µmol/L Standard Deviation 9.58

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet	0.92 mmol/L Standard Deviation 2.33

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet	-0.12 mmol/L Standard Deviation 0.46

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet	-0.23 mmol/L Standard Deviation 1.92

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet	0.14 mmol/L Standard Deviation 0.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet	-5.00 mL/min/1.73m^2 Standard Deviation 11.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet	-0.53 x10^9 neutrophils/L Standard Deviation 1.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet	-0.17 x10^9 lymphocytes/L Standard Deviation 0.47

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet	-0.06 x10^9 monocytes/L Standard Deviation 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet	0.00 x10^9 eosinophils/L Standard Deviation 0.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet	0.00 x10^9 basophils/L Standard Deviation 0.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet	-0.05 x10^12 RBC/L Standard Deviation 0.20

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet	-1.46 g/L Standard Deviation 6.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet	0.00 l/l Standard Deviation 0.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Platelet Count After 140 Days of Following Nic's Keto Diet	15.85 x10^9 platelets/L Standard Deviation 30.56

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet	0.85 fl Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet	-0.08 pg Standard Deviation 0.95

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet	-3.69 g/L Standard Deviation 7.48

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet	0.37 percentage of variation Standard Deviation 0.71

OTHER_PRE_SPECIFIED outcome

Timeframe: 140 days

Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline.

Outcome measures

Measure	Nic's Keto Diet n=13 Participants Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet	-0.20 fl Standard Deviation 0.26

Adverse Events

Nic's Keto Diet

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nic's Keto Diet n=14 participants at risk Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Skin and subcutaneous tissue disorders Acne	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Endocrine disorders Amenorrhoea	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	14.3% 2/14 • Number of events 2 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Gastrointestinal disorders Constipation	14.3% 2/14 • Number of events 4 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Investigations Haemoglobin decreased	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Number of events 3 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Gastrointestinal disorders Vomiting	14.3% 2/14 • Number of events 2 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
General disorders Malaise	14.3% 2/14 • Number of events 2 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Nervous system disorders Headache	28.6% 4/14 • Number of events 7 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Gastrointestinal disorders Dyspepsia	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Psychiatric disorders Insomnia	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Psychiatric disorders Irritability	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Nervous system disorders Dizziness	14.3% 2/14 • Number of events 2 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Psychiatric disorders Mood altered	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Injury, poisoning and procedural complications Limb injury	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Psychiatric disorders Sleep disorder	28.6% 4/14 • Number of events 4 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Nervous system disorders Insomnia	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Injury, poisoning and procedural complications Sunburn	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Gastrointestinal disorders Oropharyngeal pain	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Gastrointestinal disorders Abdominal discomfort	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Vascular disorders Vessel puncture site bruise	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.
Infections and infestations Nasopharyngitis	7.1% 1/14 • Number of events 1 • 140 days During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.

Additional Information

Nikolaos Tzenios

TRCGEN+ (managed by Trans Russian Co)

Phone: +447583902071

Email: Nicolas@trccolleges.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI is an employee of the CRO that conducted the study. The research agreement indicates that the data is the property of the sponsor and therefore they control the option for disclosing results.
• Publication restrictions are in place

Restriction type: OTHER