UBC Breakfast Study 2.0

NCT06814171 | Recruiting

• 1 other identifier: H25-00043
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Blood HbA1c

  At baseline and after 12 months

Secondary Outcomes (13)

• 24 h average glucose by continuous glucose monitoring

  Baseline, 6 and 12 months

• Post-meal areas under the curve [AUC] glucose by continuous glucose monitoring

  Baseline, 6 and 12 months

• Glycemic variability by continuous glucose monitoring

  Baseline, 6 and 12 months

• Body weight

  Baseline, 3, 6, 9 and, 12 months

• Body mass index

  Baseline, 3, 6, 9 and, 12 months

Other Outcomes (1)

• Chronotype

  Baseline

Study Arms (2)

Low-carbohydrate breakfast

EXPERIMENTAL

Other: Low-carbohydrate breakfast

Low-fat Control breakfast

ACTIVE COMPARATOR

Other: Low-fat Control breakfast

Interventions

Low-carbohydrate breakfast OTHER

Daily low-carbohydrate breakfasts for one year.

Low-carbohydrate breakfast

Low-fat Control breakfast OTHER

Low-fat breakfasts for one year.

Low-fat Control breakfast

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia - Okanagan

Kelowna, British Columbia, V1V1V7, Canada

RECRUITING

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 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Barbara Oliveira, PhD

CONTACT

250 8599900; barbara.oliveira@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)