Trial Outcomes & Findings for Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes (NCT NCT04550468)
NCT ID: NCT04550468
Last Updated: 2025-02-04
Results Overview
Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
127 participants
Primary outcome timeframe
Baseline to 12 weeks of diet
Results posted on
2025-02-04
Participant Flow
121 were included in analysis according to intention-to-treat principle
Participant milestones
| Measure |
Low-Carb High-Fat Breakfast
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
COMPLETED
|
45
|
48
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 9 • n=60 Participants
|
64 years
STANDARD_DEVIATION 10 • n=61 Participants
|
64 years
STANDARD_DEVIATION 9 • n=121 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=60 Participants
|
35 Participants
n=61 Participants
|
64 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=60 Participants
|
26 Participants
n=61 Participants
|
57 Participants
n=121 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
38 participants
n=60 Participants
|
37 participants
n=61 Participants
|
75 participants
n=121 Participants
|
|
Region of Enrollment
Australia
|
22 participants
n=60 Participants
|
24 participants
n=61 Participants
|
46 participants
n=121 Participants
|
|
Duration of T2D, mean (SD), years
|
10 years
STANDARD_DEVIATION 8 • n=60 Participants
|
9 years
STANDARD_DEVIATION 6 • n=61 Participants
|
9 years
STANDARD_DEVIATION 7 • n=121 Participants
|
|
HbA1c (%)
|
6.9 percent
STANDARD_DEVIATION 0.8 • n=60 Participants
|
7.0 percent
STANDARD_DEVIATION 0.7 • n=61 Participants
|
7.0 percent
STANDARD_DEVIATION 0.7 • n=121 Participants
|
|
Weight (kg)
|
95.8 kilograms
STANDARD_DEVIATION 26.3 • n=60 Participants
|
90.8 kilograms
STANDARD_DEVIATION 18.8 • n=61 Participants
|
93.3 kilograms
STANDARD_DEVIATION 22.9 • n=121 Participants
|
|
BMI (kg/m2)
|
33.2 kg/m2
STANDARD_DEVIATION 8.2 • n=60 Participants
|
31.4 kg/m2
STANDARD_DEVIATION 6.2 • n=61 Participants
|
32.3 kg/m2
STANDARD_DEVIATION 7.3 • n=121 Participants
|
|
Waist Circumference (cm)
|
111.1 centimeters
STANDARD_DEVIATION 16.2 • n=60 Participants
|
109.6 centimeters
STANDARD_DEVIATION 15.7 • n=61 Participants
|
110.2 centimeters
STANDARD_DEVIATION 15.9 • n=121 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks of dietHemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Change From Baseline Hemoglobin A1c at 12 Weeks
|
-0.3 % of HbA1c
Interval -0.4 to -0.1
|
-0.1 % of HbA1c
Interval -0.2 to 0.1
|
SECONDARY outcome
Timeframe: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of the interventionMean fasting blood glucose from 14 days measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Change From Baseline Fasting Blood Glucose at 12 Weeks
First 14 days
|
7.0 mmol/L
Standard Deviation 1.3
|
7.6 mmol/L
Standard Deviation 1.9
|
|
Change From Baseline Fasting Blood Glucose at 12 Weeks
Last 14 days
|
7.0 mmol/L
Standard Deviation 1.3
|
7.6 mmol/L
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks of dietPopulation: Due to logistics and budget, samples were not collected for insulin measurement.
Average fasting blood insulin measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 12 weeks of dietPopulation: Blood samples were not collected for triglycerides.
Mean triglycerides, total, HDL, and LDL cholesterol at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfas
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Change From Baseline Blood Lipids at 12 Weeks
Total cholesterol
|
-0.3 % change
Interval -9.1 to 8.5
|
-5.9 % change
Interval -13.8 to 2.0
|
|
Change From Baseline Blood Lipids at 12 Weeks
HDL cholesterol
|
-3.6 % change
Interval -7.3 to 0.1
|
-3.8 % change
Interval -7.4 to -0.2
|
|
Change From Baseline Blood Lipids at 12 Weeks
cholesterol/HDL ratio
|
13 % change
Interval 0.0 to 28.0
|
6 % change
Interval -6.0 to 19.0
|
|
Change From Baseline Blood Lipids at 12 Weeks
non-HDl cholesterol
|
5.9 % change
Interval -2.7 to 14.5
|
-1.9 % change
Interval -9.8 to 6.0
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks of dietBlood inflammation marker (hsCRP) at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks
|
10 % change
Interval -15.0 to 42.0
|
-6 % change
Interval -27.0 to 21.0
|
SECONDARY outcome
Timeframe: Weeks 1, 6 and 12Levels of hunger and satiety measured by a 0 to 100 millimeter visual analog scale \[ranges across a continuum from none (0) to an extreme amount (100) of Hunger, Satiety, Fullness, Appetite\] How hungry do you feel? How satisfied do you feel? How full do you feel? How much food do you think you can eat?
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Hunger/Satiety Levels
How hungry do you feel? week 1
|
22 score on a scale (mm)
Standard Deviation 18
|
27 score on a scale (mm)
Standard Deviation 23
|
|
Hunger/Satiety Levels
How satisfied do you feel? week 1
|
69 score on a scale (mm)
Standard Deviation 17
|
70 score on a scale (mm)
Standard Deviation 19
|
|
Hunger/Satiety Levels
How full do you feel? week 1
|
72 score on a scale (mm)
Standard Deviation 21
|
69 score on a scale (mm)
Standard Deviation 23
|
|
Hunger/Satiety Levels
How much food do you think you can eat? week 1
|
46 score on a scale (mm)
Standard Deviation 25
|
47 score on a scale (mm)
Standard Deviation 25
|
|
Hunger/Satiety Levels
How hungry do you feel? week 6
|
26 score on a scale (mm)
Standard Deviation 21
|
26 score on a scale (mm)
Standard Deviation 22
|
|
Hunger/Satiety Levels
How satisfied do you feel? week 6
|
65 score on a scale (mm)
Standard Deviation 21
|
65 score on a scale (mm)
Standard Deviation 22
|
|
Hunger/Satiety Levels
How full do you feel? week 6
|
72 score on a scale (mm)
Standard Deviation 19
|
67 score on a scale (mm)
Standard Deviation 22
|
|
Hunger/Satiety Levels
How much food do you think you can eat? week 6
|
49 score on a scale (mm)
Standard Deviation 24
|
46 score on a scale (mm)
Standard Deviation 25
|
|
Hunger/Satiety Levels
How hungry do you feel? week 12
|
29 score on a scale (mm)
Standard Deviation 25
|
26 score on a scale (mm)
Standard Deviation 23
|
|
Hunger/Satiety Levels
How satisfied do you feel? week 12
|
64 score on a scale (mm)
Standard Deviation 21
|
64 score on a scale (mm)
Standard Deviation 22
|
|
Hunger/Satiety Levels
How full do you feel? week 12
|
70 score on a scale (mm)
Standard Deviation 22
|
66 score on a scale (mm)
Standard Deviation 23
|
|
Hunger/Satiety Levels
How much food do you think you can eat? week 12
|
48 score on a scale (mm)
Standard Deviation 23
|
43 score on a scale (mm)
Standard Deviation 25
|
SECONDARY outcome
Timeframe: Mean dietary intake assessed during the 12-week interventionDietary calorie intake assessed by three 3-day food records during the 12-week intervention
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Dietary Intake
total energy
|
1701 kilocalories
Standard Deviation 510
|
1927 kilocalories
Standard Deviation 480
|
|
Dietary Intake
total carbohydrate energy
|
601 kilocalories
Standard Deviation 225
|
883 kilocalories
Standard Deviation 288
|
|
Dietary Intake
total protein energy
|
347 kilocalories
Standard Deviation 102
|
325 kilocalories
Standard Deviation 112
|
|
Dietary Intake
total fat energy
|
753 kilocalories
Standard Deviation 251
|
719 kilocalories
Standard Deviation 255
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks of dietBody weight measured in kilograms at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Change From Baseline Body Weight at 12 Weeks
|
-1.2 % change
Interval -2.3 to -0.1
|
-0.9 % change
Interval -1.9 to 0.1
|
SECONDARY outcome
Timeframe: Baseline to 12 weeks of dietBody mass Index measured in weight in kilograms divided by the square of height in meters at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Change From Baseline Body Mass Index at 12 Weeks
|
-1.2 %change
Interval -2.3 to -0.1
|
-1.1 %change
Interval -2.2 to 0.0
|
SECONDARY outcome
Timeframe: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of treatmentMeasures of overall glucose control by continuous glucose monitoring device
Outcome measures
| Measure |
Low-Carb High-Fat Breakfast
n=60 Participants
Participants followed a daily low carbohydrate high fat breakfast intervention for 3 months.
Low-Carb High-Fat breakfast: Participants received 8-10 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
|
Low Fat "Standard Care" Control Breakfast
n=61 Participants
Participants followed a daily low fat "standard care" control breakfast intervention for 3 months.
Low fat "standard care" control breakfast: Participants received 8 low-fat breakfast meal recipes to follow daily during 3 months.
|
|---|---|---|
|
Continuous Glucose Monitoring
Fasting glucose first 14 days
|
6.5 mmol/L
Standard Deviation 1.5
|
6.5 mmol/L
Standard Deviation 1.5
|
|
Continuous Glucose Monitoring
Fasting glucose last 14 days
|
7.0 mmol/L
Standard Deviation 1.9
|
6.8 mmol/L
Standard Deviation 1.7
|
Adverse Events
Low-Carb High-Fat Breakfast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Fat "Standard Care" Control Breakfast
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place