N/A
N=127
Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes
Dietary Habits
Bottom Line
View on ClinicalTrials.gov: NCT04550468 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change From Baseline Hemoglobin A1c at 12 Weeks — -0.3; -0.1 % of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low-Carb High-Fat breakfast (Other); Low fat "standard care" control breakfast (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of British Columbia
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Hemoglobin A1c at 12 Weeks |
-0.3; -0.1 | — |
| SECONDARY Change From Baseline Fasting Blood Glucose at 12 Weeks |
7.0; 7.6; 7.0; 7.6 | — |
| SECONDARY Change From Baseline Fasting Blood Insulin at 12 Weeks |
— | — |
| SECONDARY Change From Baseline Blood Lipids at 12 Weeks |
-0.3; -5.9; -3.6; -3.8; 13; 6 | — |
| SECONDARY Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks |
10; -6 | — |
| SECONDARY Hunger/Satiety Levels |
22; 27; 69; 70; 72; 69 | — |
| SECONDARY Dietary Intake |
1701; 1927; 601; 883; 347; 325 | — |
| SECONDARY Change From Baseline Body Weight at 12 Weeks |
-1.2; -0.9 | — |
| SECONDARY Change From Baseline Body Mass Index at 12 Weeks |
-1.2; -1.1 | — |
| SECONDARY Continuous Glucose Monitoring |
6.5; 6.5; 7.0; 6.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- physician-diagnosed T2D of ≥1 year;
- current HbA1c of 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
- 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;.
Data sourced from ClinicalTrials.gov (NCT04550468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.