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

University of British Columbia

Status: Completed

Conditions: Dietary Habits

Treatments: Other: Low fat "standard care" control breakfast; Other: Low-Carb High-Fat breakfast

Study type: Interventional

Funder types: Other

Identifiers

NCT04550468

H19-03179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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;.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

Low-Carb High-Fat Breakfast

Experimental group

Description:

Participants will follow a daily low carbohydrate high fat breakfast intervention for 3 months.

Treatment:

Other: Low-Carb High-Fat breakfast

Low fat "Standard Care" Control Breakfast

Active Comparator group

Description:

Participants will follow a daily low fat "standard care" control breakfast intervention for 3 months.

Treatment:

Other: Low fat "standard care" control breakfast