NCT04550468

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dietary Habits

Interventions

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

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-09-16
• Last updated: 2025-02-04
• Results posted: 2025-02-04

Locations

1 site across 1 country: Canada