Trial Outcomes & Findings for Dietary Ketosis: Fatty Acids Activate AMPK Energy Circuits Modulating Global Methylation (NCT NCT03319173)

Results Overview

Measures changes in cognitive function over time. Score: 30 points (maximum), 0 points (minimum). Score \>25 = normal cognitive function. Score 17-25 = mild cognitive impairment (MCI). Score \<17 = increased likelihood of Alzheimer's Disease or dementia.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

98 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Group Dietary interventions for subjects in the experimental group include clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation. Subjects will consume 3 meals per day with the following approximate macronutrient breakdown per meal: 65% fat, 25% protein, 10% carbohydrate. Both groups will play the Advanced PEAK brain training games on mobile devices for 75 minutes per week. Dietary intervention:Subjects in the experimental group will receive clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation. Subjects in the control group will follow the their current dietary protocol (Standard American Diet-SAD).	Control Group Dietary interventions for subjects in the control group include the subjects' current dietary protocol (Standard American Diet-SAD). Subjects will consume 4-6 small meals per day with the following approximate macronutrient breakdown per meal: 50% carbohydrate, 35% protein, 15% fat.
Overall Study STARTED	48	50
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=48 Participants Dietary interventions for subjects in the experimental group include clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation. Subjects will consume 3 meals per day with the following approximate macronutrient breakdown per meal: 65% fat, 25% protein, 10% carbohydrate. Both groups will play the Advanced PEAK brain training games on iPhone, iPad or Android devices for 75 minutes per week. Dietary intervention: Subjects in the experimental group will receive clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation.	Control Group n=50 Participants Dietary interventions for subjects in the control group include the subjects' current dietary protocol (Standard American Diet-SAD). Subjects will consume 4-6 small meals per day with the following approximate macronutrient breakdown per meal: 50% carbohydrate, 35% protein, 15% fat. Both groups will play the Advanced PEAK brain training games on iPhone, iPad or Android devices for 75 minutes per week. Dietary intervention: Subjects in the control group will follow the their current dietary protocol (Standard American Diet-SAD).	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=48 Participants	0 Participants n=50 Participants	0 Participants n=98 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=48 Participants	44 Participants n=50 Participants	85 Participants n=98 Participants
Age, Categorical >=65 years	7 Participants n=48 Participants	6 Participants n=50 Participants	13 Participants n=98 Participants
Sex: Female, Male Female	25 Participants n=48 Participants	25 Participants n=50 Participants	50 Participants n=98 Participants
Sex: Female, Male Male	23 Participants n=48 Participants	25 Participants n=50 Participants	48 Participants n=98 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	48 Participants n=48 Participants	50 Participants n=50 Participants	98 Participants n=98 Participants
MoCA (Montreal Cognitive Assessment)	28.38 units on a scale n=48 Participants	20.22 units on a scale n=50 Participants	24.30 units on a scale n=98 Participants

PRIMARY outcome

Timeframe: 12 weeks

Measures changes in cognitive function over time. Score: 30 points (maximum), 0 points (minimum). Score \>25 = normal cognitive function. Score 17-25 = mild cognitive impairment (MCI). Score \<17 = increased likelihood of Alzheimer's Disease or dementia.

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
MoCA (Montreal Cognitive Assessment)	28.38 score on a scale Standard Error 0.22	20.22 score on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: 12 weeks

Assessment of changes in Small LDL-P (total small Pattern B)

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
NMR Lipoprofile Particle Size - Small LDL-P	276.24 nmol/L Standard Error 29.25	588.08 nmol/L Standard Error 61.02

SECONDARY outcome

Timeframe: 12 weeks

Lipoprotein insulin resistance (LP-IR) is an aggregate score of the 6 lipoprotein parameters range from 0 to 100, with higher scores indicating greater insulin resistance (IR).

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
NMR Lipoprofile Particle Size - LP-IR Score (Lipoprotein Insulin Resistance) Ideal Range: <45	32.13 score on a scale Interval 28.87 to 35.76	50.66 score on a scale Interval 45.62 to 56.26

SECONDARY outcome

Timeframe: 12 weeks

Assessment of changes in fasting triglycerides over time. Ranges: \< 150 mg/dL

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
Fasting Triglycerides	87.23 mg/dL Interval 76.58 to 99.35	131.73 mg/dL Interval 115.96 to 149.64

SECONDARY outcome

Timeframe: 12 weeks

Assessment of changes in Triglyceride/HDL ratio over time.

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
Triglyceride/HDL Ratio	1.67 ratio Interval 1.41 to 1.99	2.69 ratio Interval 2.28 to 3.19

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in fasting insulin over time. Ranges: \< 2.6-11.1 mU/L

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
Fasting Insulin	7.32 mU/L Interval 6.37 to 8.42	11.25 mU/L Interval 9.81 to 12.91

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in fasting glucose over time. Ranges: \< 74-100 mg/dL

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
Fasting Glucose	85.9 mg/dL Interval 82.64 to 89.3	109.61 mg/dL Interval 105.52 to 113.85

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) over time. Ranges: \< 1.0

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
HOMA-IR	1.55 units on a scale Interval 1.32 to 1.83	3.05 units on a scale Interval 2.6 to 3.57

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in HgA1c (Hemoglobin A1c) over time.

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
HgA1c	5.19 percentage of glycated hemoglobin Interval 5.11 to 5.28	5.82 percentage of glycated hemoglobin Interval 5.73 to 5.91

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in weight over time as measured in pounds.

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
Weight	200.23 pounds Interval 189.46 to 211.62	210.60 pounds Interval 199.49 to 222.32

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in body fat mass over time as measured in pounds.

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
Body Fat Mass (BFM)	67.95 pounds Interval 62.21 to 74.21	79.35 pounds Interval 72.78 to 86.52

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in VLDL (very low density lipoprotein carrier) over time. Ranges: \< 5-40 mg/dL

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
VLDL	17.45 mg/dL Interval 15.32 to 19.87	26.35 mg/dL Interval 23.19 to 29.93

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in SAM/SAH (S-adenosylmethionine/S-adenosylhomocysteine) ratio Range: \>4.0

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
SAM/SAH Ratio (S-adenosylmethionine/S-adenosylhomocysteine)	4.938 ratio Interval 4.538 to 5.372	4.491 ratio Interval 4.119 to 4.896

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in SAM (S-adenosylmethionine)

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
SAM (S-adenosylmethionine)	89.784 nmol/L Interval 84.767 to 95.099	88.177 nmol/L Interval 83.131 to 93.529

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in SAH (S-adenosylhomocysteine) Range: 10-22 nmol/L

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
SAH (S-adenosylhomocysteine)	18.257 nmol/L Interval 17.685 to 18.847	19.566 nmol/L Interval 18.938 to 20.214

SECONDARY outcome

Timeframe: 12-weeks

Assessment of changes in Adenosine Range: 20-80 nmol/L

Outcome measures

Outcome measures
Measure	Experimental Group n=48 Participants MoCA post intervention score	Control Group n=50 Participants MoCA post intervention score
Adenosine	23.363 nmol/L Interval 22.413 to 24.352	21.475 nmol/L Interval 20.581 to 22.407

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kelly J. Gibas

Bristlecone Health, Inc.

Phone: 763-913-4600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place