UBC Breakfast Study 2.0
Recruiting · NCT06814171 · Interventional (participants receive a specific treatment) · Lead sponsor: University of British Columbia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- University of British Columbia - Okanagan - Kelowna, British Columbia, Canada