Low-calorie Diet in Isolated Impaired Fasting Glucose

NCT ID: NCT06451055

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2026-12-30

Brief 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.

Detailed 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.

Conditions

Isolated Impaired Fasting Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Low-calorie diet

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.

Group Type: EXPERIMENTAL

Low-calorie diet

Intervention Type: BEHAVIORAL

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.

Routine dietary and physical activity habits

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

Group Type: ACTIVE_COMPARATOR

Routine dietary and physical activity habits

Intervention Type: BEHAVIORAL

Participants are asked to maintain their habitual dietary and physical activity habits for the 8-week study period.

Interventions

Low-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.

Intervention Type: BEHAVIORAL

Routine dietary and physical activity habits

Participants are asked to maintain their habitual dietary and physical activity habits for the 8-week study period.

Intervention Type: BEHAVIORAL

Other Intervention Names

Dietary energy restriction

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Sathish Thirunavukkarasu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sathish Thirunavukkarasu, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs)

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Sathish Thirunavukkarasu, PhD

Role: CONTACT

sathish.thirunavukkarasu@emory.edu

(404) 778-3771

Other Identifiers

STUDY00007848

Identifier Type: -

Identifier Source: org_study_id