Effect of Dietary Energy Restriction on Reversing Isolated Impaired Fasting Glucose: A Proof of Concept Study
Emory University
Summary
This study aims to evaluate the preliminary efficacy of a low-calorie diet (LCD) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with isolated impaired fasting glucose (i-IFG). Additionally, it seeks to assess the feasibility and acceptability of the LCD intervention.
Description
This proof-of-concept randomized controlled trial (RCT) will enroll 34 individuals aged 35-65 years with overweight or obesity and isolated impaired fasting glucose. Intervention participants will adhere to an 8-week low-calorie dietary (LCD) regimen (\~1,320 kcal/day) comprising specific macronutrient proportions (55% carbohydrate, 13% fat, 25% protein, and 2% fiber). Control participants will maintain their habitual dietary habits and physical activity levels. Primary outcomes at 8 weeks include between-group changes in weight, fasting plasma glucose, indices of ß-cell function and hepatic i…
Eligibility
- Age range
- 35–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Aged 35 to 65 years 2. Overweight (body mass index (BMI) ≥25 to \<29 kg/m² or ≥23 to \<29 kg/m² if Asian descent) or Obese (BMI ≥30 kg/m²) 3. Physically inactive (\<150 minutes per week of moderate-intensity physical activity or \<75 minutes per week of vigorous-intensity physical activity) 4. Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool Exclusion Criteria: 1. Diagnosed with type 1 or type 2 diabetes 2. Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions) 3. Chronic kidney…
Interventions
- BehavioralLow-calorie diet
The low-calorie diet consists of approximately 1,300 kcal/day (37% carbohydrates, 25% protein, 39% fat, and 7 g of fiber per meal) over an eight-week period. Participants receive weekly pre-prepared meals from Trifecta Nutrition (Trifecta Inc. California, USA) with options for breakfast, lunch, and dinner, meticulously crafted by certified dieticians and expert chefs. Participants are encouraged to consume 1-2 liters of water daily and maintain their habitual physical activity levels.
- BehavioralRoutine dietary and physical activity habits
Participants are asked to maintain their habitual dietary and physical activity habits for the 8-week study period.
Location
- Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs)Atlanta, Georgia