Low-calorie Diet in Isolated Impaired Fasting Glucose

Emory University

Status: Begins enrollment in 3 months

Conditions: Isolated Impaired Fasting Glucose

Treatments: Behavioral: Routine dietary and physical activity habits; Behavioral: Low-calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06451055

STUDY00007848

Details and patient eligibility

About

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.

Full 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 insulin resistance, and alanine aminotransferase levels. Secondary outcomes are feasibility metrics (response rate, screening yield, enrollment rate, intervention compliance, cost, staff time, and retention rate) and intervention acceptability. Qualitative research will explore facilitators, barriers, acceptability, satisfaction, and participant experiences with the LCD intervention.

Enrollment: 34 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 disease
4. Chronic liver disease (e.g., cirrhosis)
5. Cancers
6. Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption
7. Food allergies
8. Participation in weight loss programs in the past six months
9. Currently following a specific diet (e.g., ketogenic diet, Mediterranean diet)
10. Participation in any exercise programs in the past six months
11. Currently taking weight-loss medications or drugs known to affect glycemia (steroids and antipsychotics)
12. Previous bariatric surgery or plan to have bariatric surgery during the study period
13. Planning to relocate during the study period
14. Intending to fast during the study period for religious or other reasons
15. Pregnancy or planning to become pregnant during the study period
16. Breastfeeding
17. Non-English speaker

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Low-calorie diet

Experimental group

Description:

Participants following a low-calorie diet (LCD) consisting of approximately 1,300 kcal/day (37% carbohydrates, 25% protein, 39% fat, and 7 g of fiber per meal) over an eight-week period.

Treatment:

Behavioral: Low-calorie diet

Routine dietary and physical activity habits

Active Comparator group

Description:

Control participants are asked to maintain their routine dietary and physical activity habits.

Treatment:

Behavioral: Routine dietary and physical activity habits