Clinical trial NCT04550468: Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes
Official title: Impact of a Low-carbohydrate Versus Low-fat Breakfast on Blood Glucose Control in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Wollongong
First posted: 2020-09-16
Enrollment: 127
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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;.

Primary outcomes:
measure: Change From Baseline Hemoglobin A1c at 12 Weeks
timeFrame: Baseline to 12 weeks of diet
Secondary outcomes:
measure: Change From Baseline Fasting Blood Glucose at 12 Weeks
timeFrame: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of the intervention
measure: Change From Baseline Fasting Blood Insulin at 12 Weeks
timeFrame: Baseline to 12 weeks of diet
measure: Change From Baseline Blood Lipids at 12 Weeks
timeFrame: Baseline to 12 weeks of diet
measure: Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks
timeFrame: Baseline to 12 weeks of diet
measure: Hunger/Satiety Levels
timeFrame: Weeks 1, 6 and 12
measure: Dietary Intake
timeFrame: Mean dietary intake assessed during the 12-week intervention
measure: Change From Baseline Body Weight at 12 Weeks
timeFrame: Baseline to 12 weeks of diet
measure: Change From Baseline Body Mass Index at 12 Weeks
timeFrame: Baseline to 12 weeks of diet
measure: Continuous Glucose Monitoring
timeFrame: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of treatment
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
References: