CompletedNCT04550468Updated Feb 4, 2025Results posted

Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes

An interventional study of Low-Carb High-Fat breakfast and Low fat "standard care" control breakfast in Dietary Habits, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by University of British Columbia · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 127
Allocation: Randomized
Ages: 20 Years to 79 Years
Sex: All

Study summary

The prevalence of type 2 diabetes (T2D) is increasing worldwide, with \~380 M currently suffering from this chronic, debilitating disease. T2D is characterized by high blood glucose levels in the mornings and after meals. The largest hyperglycemic spike often occurs after breakfast. Targeting this meal may be a simple, feasible strategy to improve glycemic control and reduce risk for diabetes complications. It is hypothesized that consuming a low carbohydrate high fat (LCHF) breakfast for 3 months, when compared to a standard low-fat breakfast will improve blood glucose control, increase satiety and improve body composition in people with T2D. This information will test whether the simple dietary strategy of limiting carbohydrates at breakfast could help in managing T2D.

Read the detailed description

A 3-month parallel-group randomized controlled trial will be conducted. Eligible participants will be randomized to either the Low-carb High-fat breakfast (LCHF, n=41) or a low-fat "standard care" control breakfast (CTL, n=41), to be consumed daily for a period of 3 months.

Due to COVID-19 pandemic, this study was adapted to be conducted remotely through video/telephone conference meetings between participants and study staff, along with mailing of study materials before and after the intervention for remote data collection.

Each group will be provided with a menu of 8 LCHF breakfasts or 8 CTL breakfasts from which to choose each morning. Breakfast options (designed by a registered dietitian) will be controlled in macronutrient content and calories (\~400-500 kcal), but allow for personal preference and autonomy to promote adherence.

Conditions studied

Dietary Habits

In context

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

physician-diagnosed T2D of ≥1 year;
current HbA1c of \< 8.5%;
BMI: >25 kg/m2; (as of July 5, 2021, BMI cut off was expanded from 25-40 kg/m2 to higher than 25kg/m2 to facilitate recruitment)
blood pressure of \<160/99 mm Hg assessed according to guidelines;
non-smoking;
not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications;
20-79 years old.

Exclusion criteria

Exclusion Criteria:

Use of exogenous insulin;
taking more than 2 glucose lowering medications;
ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders;
allergy, intolerance or aversion to eggs or any other dietary restrictions (e.g., vegan, breakfast skipping) that will prevent them from following the standardized study diets;
being unable to follow remote guidance by internet or smartphone
being unable to follow the controlled diet instructions;.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 127 participants (actual)

Study arms

Experimental
Low-Carb High-Fat Breakfast
Participants will follow a daily low carbohydrate high fat breakfast intervention for 3 months.
Other: Low-Carb High-Fat breakfast
Active comparator
Low fat "Standard Care" Control Breakfast
Participants will follow a daily low fat "standard care" control breakfast intervention for 3 months.
Other: Low fat "standard care" control breakfast

Interventions

OtherLow-Carb High-Fat breakfast
Participants will receive 8 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
OtherLow fat "standard care" control breakfast
Participants will receive 8 low-fat breakfast meal recipes to follow daily during 3 months.

What researchers measure

Primary outcomes

Change From Baseline Hemoglobin A1c at 12 Weeks
Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Time frame: Baseline to 12 weeks of diet

Secondary outcomes

Change From Baseline Fasting Blood Glucose at 12 Weeks
Mean fasting blood glucose from 14 days measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Time frame: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of the intervention
Change From Baseline Fasting Blood Insulin at 12 Weeks
Average fasting blood insulin measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Time frame: Baseline to 12 weeks of diet
Change From Baseline Blood Lipids at 12 Weeks
Mean triglycerides, total, HDL, and LDL cholesterol at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfas
Time frame: Baseline to 12 weeks of diet
Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks
Blood inflammation marker (hsCRP) at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Time frame: Baseline to 12 weeks of diet
Hunger/Satiety Levels
Levels 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?
Time frame: Weeks 1, 6 and 12
Dietary Intake
Dietary calorie intake assessed by three 3-day food records during the 12-week intervention
Time frame: Mean dietary intake assessed during the 12-week intervention
Change From Baseline Body Weight at 12 Weeks
Body weight measured in kilograms at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Time frame: Baseline to 12 weeks of diet
Change From Baseline Body Mass Index at 12 Weeks
Body 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
Time frame: Baseline to 12 weeks of diet
Continuous Glucose Monitoring
Measures of overall glucose control by continuous glucose monitoring device
Time frame: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of treatment

Results

Posted Feb 4, 2025

Participant flow

Participant flow — Overall Study
Milestone	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
Started	64	63
Completed	45	48
Not completed	19	15

Outcome measures

PrimaryChange From Baseline Hemoglobin A1c at 12 Weeks

Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

Time frame:: Baseline to 12 weeks of diet
Reported as:: Mean · % of HbA1c

Change From Baseline Hemoglobin A1c at 12 Weeks
% of HbA1c	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
Change From Baseline Hemoglobin A1c at 12 Weeks	-0.3 (-0.4 to -0.1)	-0.1 (-0.2 to 0.1)

SecondaryChange From Baseline Fasting Blood Glucose at 12 Weeks

Mean fasting blood glucose from 14 days measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

Time frame:: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of the intervention
Reported as:: Mean · mmol/L

Change From Baseline Fasting Blood Glucose at 12 Weeks
mmol/L	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
First 14 days	7.0 ± 1.3	7.6 ± 1.9
Last 14 days	7.0 ± 1.3	7.6 ± 1.7

SecondaryChange From Baseline Fasting Blood Insulin at 12 Weeks

Average fasting blood insulin measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

Time frame:: Baseline to 12 weeks of diet

No measurements were reported for this outcome.

SecondaryChange From Baseline Blood Lipids at 12 Weeks

Mean triglycerides, total, HDL, and LDL cholesterol at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfas

Time frame:: Baseline to 12 weeks of diet
Reported as:: Mean · % change

Change From Baseline Blood Lipids at 12 Weeks
% change	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
Total cholesterol	-0.3 (-9.1 to 8.5)	-5.9 (-13.8 to 2.0)
HDL cholesterol	-3.6 (-7.3 to 0.1)	-3.8 (-7.4 to -0.2)
cholesterol/HDL ratio	13 (0 to 28)	6 (-6 to 19)
non-HDl cholesterol	5.9 (-2.7 to 14.5)	-1.9 (-9.8 to 6)

SecondaryChange From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks

Blood inflammation marker (hsCRP) at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

Time frame:: Baseline to 12 weeks of diet
Reported as:: Mean · % change

Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks
% change	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks	10 (-15 to 42)	-6 (-27 to 21)

SecondaryHunger/Satiety Levels

Levels 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?

Time frame:: Weeks 1, 6 and 12
Reported as:: Mean · score on a scale (mm)

Hunger/Satiety Levels
score on a scale (mm)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
How hungry do you feel? week 1	22 ± 18	27 ± 23
How satisfied do you feel? week 1	69 ± 17	70 ± 19
How full do you feel? week 1	72 ± 21	69 ± 23
How much food do you think you can eat? week 1	46 ± 25	47 ± 25
How hungry do you feel? week 6	26 ± 21	26 ± 22
How satisfied do you feel? week 6	65 ± 21	65 ± 22
How full do you feel? week 6	72 ± 19	67 ± 22
How much food do you think you can eat? week 6	49 ± 24	46 ± 25
How hungry do you feel? week 12	29 ± 25	26 ± 23
How satisfied do you feel? week 12	64 ± 21	64 ± 22
How full do you feel? week 12	70 ± 22	66 ± 23
How much food do you think you can eat? week 12	48 ± 23	43 ± 25

SecondaryDietary Intake

Dietary calorie intake assessed by three 3-day food records during the 12-week intervention

Time frame:: Mean dietary intake assessed during the 12-week intervention
Reported as:: Mean · kilocalories

Dietary Intake
kilocalories	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
total energy	1701 ± 510	1927 ± 480
total carbohydrate energy	601 ± 225	883 ± 288
total protein energy	347 ± 102	325 ± 112
total fat energy	753 ± 251	719 ± 255

SecondaryChange From Baseline Body Weight at 12 Weeks

Body weight measured in kilograms at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

Time frame:: Baseline to 12 weeks of diet
Reported as:: Mean · % change

Change From Baseline Body Weight at 12 Weeks
% change	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
Change From Baseline Body Weight at 12 Weeks	-1.2 (-2.3 to -0.1)	-0.9 (-1.9 to 0.1)

SecondaryChange From Baseline Body Mass Index at 12 Weeks

Body 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

Time frame:: Baseline to 12 weeks of diet
Reported as:: Mean · %change

Change From Baseline Body Mass Index at 12 Weeks
%change	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
Change From Baseline Body Mass Index at 12 Weeks	-1.2 (-2.3 to -0.1)	-1.1 (-2.2 to 0.0)

SecondaryContinuous Glucose Monitoring

Measures of overall glucose control by continuous glucose monitoring device

Time frame:: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of treatment
Reported as:: Mean · mmol/L

Continuous Glucose Monitoring
mmol/L	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast
Fasting glucose first 14 days	6.5 ± 1.5	6.5 ± 1.5
Fasting glucose last 14 days	7.0 ± 1.9	6.8 ± 1.7

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Low-Carb High-Fat Breakfast	0/64 (0%)	0/64 (0%)	0/64 (0%)
Low Fat "Standard Care" Control Breakfast	0/63 (0%)	0/63 (0%)	0/63 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast	Total
Mean	65 ± 9	64 ± 10	64 ± 9

Sex: Female, Male
Sex: Female, Male(Participants)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast	Total
Female	29	35	64
Male	31	26	57

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast	Total
Canada	38	37	75
Australia	22	24	46

Duration of T2D, mean (SD), years
Duration of T2D, mean (SD), years(years)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast	Total
Mean	10 ± 8	9 ± 6	9 ± 7

HbA1c (%)
HbA1c (%)(percent)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast	Total
Mean	6.9 ± 0.8	7.0 ± 0.7	7.0 ± 0.7

Weight (kg)
Weight (kg)(kilograms)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast	Total
Mean	95.8 ± 26.3	90.8 ± 18.8	93.3 ± 22.9

BMI (kg/m2)
BMI (kg/m2)(kg/m2)	Low-Carb High-Fat Breakfast	Low Fat "Standard Care" Control Breakfast	Total
Mean	33.2 ± 8.2	31.4 ± 6.2	32.3 ± 7.3

1 further baseline measures are reported on the registry.

Study locations

1 site

University of British Columbia
Kelowna, British Columbia V1V 1V7, Canada

References and documents

Study documents

Study protocol · Oct 1, 2021
Statistical analysis plan · Jun 23, 2022

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04550468
Lead sponsor: University of British Columbia
Collaborators: University of Wollongong
Responsible party: Jonathan Little (Associate Professor, University of British Columbia) — Principal investigator
First posted: Sep 16, 2020
Start date: Oct 1, 2020
Primary completion: Jun 30, 2022
Completion: Jun 30, 2022
Results posted: Feb 4, 2025
Last update: Feb 4, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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