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

NCT ID: NCT04550468

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-06-30

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.

Conditions

Dietary Habits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low-Carb High-Fat Breakfast

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

Group Type: EXPERIMENTAL

Low-Carb High-Fat breakfast

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

Low fat "standard care" control breakfast

Intervention Type: OTHER

Participants will receive 8 low-fat breakfast meal recipes to follow daily during 3 months.

Interventions

Low-Carb High-Fat breakfast

Participants will receive 8 low-carb high-fat breakfast meal recipes to follow daily during 3 months.

Intervention Type: OTHER

Low fat "standard care" control breakfast

Participants will receive 8 low-fat breakfast meal recipes to follow daily during 3 months.

Intervention Type: OTHER

Eligibility Criteria

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;.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wollongong

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Little

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of British Columbia

Kelowna, British Columbia, Canada

Countries

Canada

References

Oliveira BF, Chang CR, Oetsch K, Falkenhain K, Crampton K, Stork M, Hoonjan M, Elliott T, Francois ME, Little JP. Impact of a Low-Carbohydrate Compared with Low-Fat Breakfast on Blood Glucose Control in Type 2 Diabetes: A Randomized Trial. Am J Clin Nutr. 2023 Jul;118(1):209-217. doi: 10.1016/j.ajcnut.2023.04.032. Epub 2023 May 29.

Reference Type: DERIVED

PMID: 37257563 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H19-03179

Identifier Type: -

Identifier Source: org_study_id