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Completed

NCT Number: NCT04550468

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

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Feeding Behavior

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;.

Treatment and study plan

Low-Carb High-Fat breakfast

Other

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

Low fat "standard care" control breakfast

Other

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

Primary outcomes

  1. Change From Baseline Hemoglobin A1c at 12 Weeks

    Time frame: Baseline to 12 weeks of diet

    Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

Secondary outcomes

  1. Change From Baseline Fasting Blood Glucose at 12 Weeks

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

    Mean fasting blood glucose from 14 days measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

  2. Change From Baseline Fasting Blood Insulin at 12 Weeks

    Time frame: Baseline to 12 weeks of diet

    Average fasting blood insulin measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

  3. Change From Baseline Blood Lipids at 12 Weeks

    Time frame: Baseline to 12 weeks of diet

    Mean triglycerides, total, HDL, and LDL cholesterol at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfas

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

    Time frame: Baseline to 12 weeks of diet

    Blood inflammation marker (hsCRP) at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

  5. Hunger/Satiety Levels

    Time frame: Weeks 1, 6 and 12

    Levels of hunger and satiety measured by a 0 to 100 millimeter visual analog scale [ranges across a continuum from none (0) to an extreme amount (100) of Hunger, Satiety, Fullness, Appetite] How hungry do you feel? How satisfied do you feel? How full do you feel? How much food do you think you can eat?

  6. Dietary Intake

    Time frame: Mean dietary intake assessed during the 12-week intervention

    Dietary calorie intake assessed by three 3-day food records during the 12-week intervention

  7. Change From Baseline Body Weight at 12 Weeks

    Time frame: Baseline to 12 weeks of diet

    Body weight measured in kilograms at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

  8. Change From Baseline Body Mass Index at 12 Weeks

    Time frame: Baseline to 12 weeks of diet

    Body mass Index measured in weight in kilograms divided by the square of height in meters at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

  9. Continuous Glucose Monitoring

    Time frame: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of treatment

    Measures of overall glucose control by continuous glucose monitoring device

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • University of Wollongong

Registry information

Official study title

Impact of a Low-carbohydrate Versus Low-fat Breakfast on Blood Glucose Control in Type 2 Diabetes

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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