Low-calorie Diet in Isolated Impaired Fasting Glucose

NCT06451055 | Not Yet Recruiting

• 1 other identifier: STUDY00007848
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Isolated Impaired Fasting Glucose

Keywords

Low-calorie diet; Prediabetes; Overweight; Obesity; Fasting hyperglycemia

Outcome Measures

Primary Outcomes (9)

• Response rate

  Response rate is defined as the proportion of individuals responding to the invitation sent via the Epic database.

  Baseline

• Screening yield

  Screening yield: Proportion of screened individuals meeting eligibility criteria.

  Baseline

• Enrollment rate

  Enrollment rate: Proportion of eligible individuals who enroll in the study.

  Baseline

• Resource utilization

  Resource utilization: Assessment of expenditures and staff time.

  Throughout the study period, an average of 10 weeks

• Retention rate

  Retention rate: Proportion of enrolled participants who complete the study.

  4 and 8 weeks

• Intervention acceptability

  Intervention acceptability will be assessed using the Theoretical Framework of Acceptability questionnaire. Scores range from 7 to 35. Higher scores indicate better acceptability among participants.

  4 and 8 weeks

• Feasibility of intervention

  Will be assessed using the Feasibility of Intervention Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better feasibility among participants.

  4 and 8 weeks

• Intervention appropriateness

  Will be assessed with the Intervention Appropriateness Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better appropriateness among participants.

  4 and 8 weeks

• Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention

  Qualitative in-depth interviews

  4 and 8 weeks

Secondary Outcomes (7)

• Weight in kg

  4 and 8 weeks

• Fasting plasma glucose in mg/dl

  4 and 8 weeks

• Indices of ß-cell function

  4 and 8 weeks

• ß-cell function assessed by Oral Disposition Index (DI(O))

  4 and 8 weeks

• ß-cell function assessed by Homeostatic Model Assessment of ß-cell Function (HOMA-B)

  4 and 8 weeks

Study Arms (2)

Low-calorie diet

EXPERIMENTAL

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.

Behavioral: Low-calorie diet

Routine dietary and physical activity habits

ACTIVE COMPARATOR

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

Behavioral: Routine dietary and physical activity habits

Interventions

Low-calorie diet 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.

Also known as: Dietary energy restriction

Low-calorie diet

Routine dietary and physical activity habits BEHAVIORAL

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

Routine dietary and physical activity habits

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 35 to 65 years
• 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)
• Physically inactive (\<150 minutes per week of moderate-intensity physical activity or \<75 minutes per week of vigorous-intensity physical activity)
• Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool

You may not qualify if:

• Diagnosed with type 1 or type 2 diabetes
• Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions)
• Chronic kidney disease
• Chronic liver disease (e.g., cirrhosis)
• Cancers
• Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption
• Food allergies
• Participation in weight loss programs in the past six months
• Currently following a specific diet (e.g., ketogenic diet, Mediterranean diet)
• Participation in any exercise programs in the past six months
• Currently taking weight-loss medications or drugs known to affect glycemia (steroids and antipsychotics)
• Previous bariatric surgery or plan to have bariatric surgery during the study period
• Planning to relocate during the study period
• Intending to fast during the study period for religious or other reasons
• Pregnancy or planning to become pregnant during the study period

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

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

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sathish Thirunavukkarasu, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sathish Thirunavukkarasu, PhD

CONTACT

(404) 778-3771; sathish.thirunavukkarasu@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Nursing staff conducting outcome assessments and laboratory personnel will be blinded to participants' treatment status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 10, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)