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

Study Overview
=================
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.

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

Conditions
-----------------
Dietary Habits

Intervention / Treatment
-----------------
* Other: Low-Carb High-Fat breakfast
* Other: Low fat standard care control breakfast


Participation Criteria
=================
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;.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Carb High-Fat Breakfast<br>Participants will follow a daily low carbohydrate high fat breakfast intervention for 3 months. | Other: Low-Carb High-Fat breakfast<br>* Participants will receive 8 low-carb high-fat breakfast meal recipes to follow daily during 3 months.<br>|
| Active Comparator: Low fat Standard Care Control Breakfast<br>Participants will follow a daily low fat standard care control breakfast intervention for 3 months. | Other: Low fat standard care control breakfast<br>* Participants will receive 8 low-fat breakfast meal recipes to follow daily during 3 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Hemoglobin A1c at 12 weeks | Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast | Baseline to 12 weeks of diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Fasting blood glucose at 12 weeks | Fasting blood glucose measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast | Baseline to 12 weeks of diet | 
| Change from Baseline Fasting blood insulin at 12 weeks | Fasting blood insulin measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast | Baseline to 12 weeks of diet | 
| Change from Baseline Blood Lipids at 12 weeks | Triglycerides, total, HDL, and LDL cholesterol at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast | Baseline to 12 weeks of diet | 
| Change from Baseline Inflammation marker High sensitive Reactive Protein (hsCRP) at 12 weeks | Blood inflammation marker (hsCRP) at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast | Baseline to 12 weeks of diet | 
| Hunger/satiety levels | 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] | 12 weeks | 
| Change from Baseline Caloric intake at 12 weeks | Total calorie intake assessed by 24 hour food record | Baseline to 12 weeks of diet | 
| Change from Baseline Body weight at 12 weeks | Body weight measured in kilograms at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast | Baseline to 12 weeks of diet | 
| Change from Baseline Body Mass Index at 12 weeks | 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 | Baseline to 12 weeks of diet | 
| Continuous glucose monitoring | Measures of overall glucose control by continuous glucose monitoring device | first 14 days and last 14 days of the study |