Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes
- Conditions
- Dietary Habits
- Interventions
- Other: Low-Carb High-Fat breakfastOther: Low fat "standard care" control breakfast
- Registration Number
- NCT04550468
- Lead Sponsor
- University of British Columbia
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-Carb High-Fat Breakfast Low-Carb High-Fat breakfast Participants will follow a daily low carbohydrate high fat breakfast intervention for 3 months. Low fat "Standard Care" Control Breakfast Low fat "standard care" control breakfast Participants will follow a daily low fat "standard care" control breakfast intervention for 3 months.
- Primary Outcome Measures
Name Time Method Change from Baseline Hemoglobin A1c at 12 weeks Baseline to 12 weeks of diet Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
- Secondary Outcome Measures
Name Time Method Change from Baseline Fasting blood glucose at 12 weeks Baseline to 12 weeks of diet Fasting blood glucose measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Change from Baseline Fasting blood insulin at 12 weeks Baseline to 12 weeks of diet Fasting blood insulin measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Change from Baseline Blood Lipids at 12 weeks Baseline to 12 weeks of diet Triglycerides, total, HDL, and LDL cholesterol at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Change from Baseline Inflammation marker High sensitive Reactive Protein (hsCRP) at 12 weeks Baseline to 12 weeks of diet Blood inflammation marker (hsCRP) at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Hunger/satiety levels 12 weeks Levels of hunger and satiety measured by a 0 to 100 millimeter visual analog scale \[ranges across a continuum from none (0) to an extreme amount (100) of Hunger, Satiety, Fullness, Appetite\]
Change from Baseline Caloric intake at 12 weeks Baseline to 12 weeks of diet Total calorie intake assessed by 24 hour food record
Change from Baseline Body weight at 12 weeks Baseline to 12 weeks of diet Body weight measured in kilograms at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Change from Baseline Body Mass Index at 12 weeks Baseline to 12 weeks of diet 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
Continuous glucose monitoring first 14 days and last 14 days of the study Measures of overall glucose control by continuous glucose monitoring device
Trial Locations
- Locations (1)
University of British Columbia
🇨🇦Kelowna, British Columbia, Canada