Recruiting

Low-Carbohydrate Breakfast

Sponsor:

University of British Columbia

Code:

NCT06814171

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Low-carbohydrate breakfast

Low-fat Control breakfast

Study Details

Brief summary:

Type 2 diabetes (T2D), a prevalent metabolic disorder impacting >3 million Canadians, is characterized by insulin resistance and high blood glucose. Chronically elevated blood glucose (i.e., hyperglycemia) and swings in glucose (i.e., glucose variability) contribute to complications of T2D. Specifically, post-meal hyperglycemic spikes are independent risk factors for cardiovascular disease and mortality. People with T2D often exhibit a different circadian pattern from healthy individuals, with higher glucose excursions in the morning, after breakfast. This makes breakfast a crucial meal in achieving glycemic control. One strategy to reduce or eliminate this high glucose excursion is to consume a low-carbohydrate breakfast. Our recently published 3-month clinical trial (Oliveira et al., AJCN 2023) - funded by the Egg Farmers of Canada (EFC) \& Egg Nutrition Center (ENC) - highlighted the positive impact of a simple dietary intervention, where individuals were advised to consume an egg-based, low-carbohydrate breakfast. This intervention led to improved glycemic control assessed by continuous glucose monitoring and reduced overall energy and carbohydrate intake when compared to a low-fat guideline breakfast. While we saw a within-group reduction HbA1c in the egg-based low-carbohydrate breakfast group, the between group difference did not reach statistical significance. Since HbA1c reflects the average glucose over the preceding 3 months, likely, our previous study's duration was not long enough to demonstrate significant reductions in HbA1c. For a low-carbohydrate breakfast to be recognized as an evidence-based strategy in nutrition and clinical practice guidelines, a longer-term study that demonstrates reductions in HbA1c is needed.

Collectively, our promising early results demonstrate that the time is right and that our team is poised to deliver a longer, well-powered randomized controlled trial (RCT) to solidify low-carbohydrate breakfasts as an evidence-based strategy to improve glucose control and improve health outcomes for people living with T2D.

Conditions

Type 2 Diabetes

Study ID

NCT06814171

Start date

Apr 1, 2025

Status verified date

Jun, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

i) physician-diagnosed T2D, ii) 30-79 years old and iii) on stable medication for at least 3 months

Exclusion Criteria:

i) Use of exogenous insulin; ii) taking more than 3 glucose lowering medications; iii) ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, or kidney disorders; iv) 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; v) being unable to follow the controlled diet instructions; vi) currently following a low-carbohydrate or very low-carbohydrate diet (ketogenic diet); vii) currently pregnant or lactating, or planning on becoming pregnant within the next 12 months; viii) with scheduled surgery or medical intervention that prevents following study diet; and ix) being unable to follow remote guidance by internet or smartphone.

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low-carbohydrate breakfast

active comparator: Low-fat Control breakfast

Interventions

Low-carbohydrate breakfast

Daily low-carbohydrate breakfasts for one year.

Low-fat Control breakfast

Low-fat breakfasts for one year.

Primary outcome measure

  • HbA1c [ Time Frame: At baseline and after 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of British Columbia - Okanagan

Recruiting

Kelowna, British Columbia, Canada, V1V1V7

More Information

Sponsor

University of British Columbia

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-06-10.