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

NCT04550468 | Completed Results

• 1 other identifier: H19-03179
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Habits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change From Baseline Fasting Blood Glucose at 12 Weeks

  Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of the intervention

• Change From Baseline Fasting Blood Insulin at 12 Weeks

  Baseline to 12 weeks of diet

• Change From Baseline Blood Lipids at 12 Weeks

  Baseline to 12 weeks of diet

• Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks

  Baseline to 12 weeks of diet

• Hunger/Satiety Levels

  Weeks 1, 6 and 12

Study Arms (2)

Low-Carb High-Fat Breakfast

EXPERIMENTAL

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

Other: Low-Carb High-Fat breakfast

Low fat "Standard Care" Control Breakfast

ACTIVE COMPARATOR

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

Other: Low fat "standard care" control breakfast

Interventions

Low-Carb High-Fat breakfast OTHER

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

Low-Carb High-Fat Breakfast

Low fat "standard care" control breakfast OTHER

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

Low fat "Standard Care" Control Breakfast

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years old.

You may not qualify if:

• 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;.

Sponsors & Collaborators

• University of British Columbia: lead
• University of Wollongong: collaborator

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (1)

• 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.

  PMID: 37257563 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Results Point of Contact

• Title: Dr. Jonathan Little
• Organization: University of British Columbia

jonathan.little@ubc.ca

250-807-9876

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-02

Locations

CA (1)