Low-calorie Diet in Isolated Impaired Fasting Glucose

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06451055
Status
Not Yet Recruiting

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Conditions

  • Isolated Impaired Fasting Glucose

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jan 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • Active Comparator: Routine dietary and physical activity habits
    Control participants are asked to maintain their routine dietary and physical activity habits.

Primary Outcome Measure

Response rate [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs)AtlantaGeorgia30322-

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Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs)· Atlanta, GA