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

Dietary Habits Clinical Trial

Official title:

Impact of a Low-carbohydrate Versus Low-fat Breakfast on Blood Glucose Control in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550468
• Other study ID #: H19-03179
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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:

• 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;.

Related Conditions & MeSH terms

• Dietary Habits

Intervention

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

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	University of Wollongong

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to 12 weeks of diet
Secondary	Change from Baseline Fasting blood glucose at 12 weeks	Fasting blood glucose measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast	Baseline to 12 weeks of diet
Secondary	Change from Baseline Fasting blood insulin at 12 weeks	Fasting blood insulin measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast	Baseline to 12 weeks of diet
Secondary	Change from Baseline Blood Lipids at 12 weeks	Triglycerides, total, HDL, and LDL cholesterol at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast	Baseline to 12 weeks of diet
Secondary	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	Baseline to 12 weeks of diet
Secondary	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]	12 weeks
Secondary	Change from Baseline Caloric intake at 12 weeks	Total calorie intake assessed by 24 hour food record	Baseline to 12 weeks of diet
Secondary	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	Baseline to 12 weeks of diet
Secondary	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	Baseline to 12 weeks of diet
Secondary	Continuous glucose monitoring	Measures of overall glucose control by continuous glucose monitoring device	first 14 days and last 14 days of the study