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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
34
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.
Participants are asked to maintain their habitual dietary and physical activity habits for the 8-week study period.
Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs)
Atlanta, Georgia, United States
Response rate
Response rate is defined as the proportion of individuals responding to the invitation sent via the Epic database.
Time frame: Baseline
Screening yield
Screening yield: Proportion of screened individuals meeting eligibility criteria.
Time frame: Baseline
Enrollment rate
Enrollment rate: Proportion of eligible individuals who enroll in the study.
Time frame: Baseline
Resource utilization
Resource utilization: Assessment of expenditures and staff time.
Time frame: Throughout the study period, an average of 10 weeks
Retention rate
Retention rate: Proportion of enrolled participants who complete the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 4 and 8 weeks
Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention
Qualitative in-depth interviews
Time frame: 4 and 8 weeks
Weight in kg
Weight will be measured using a digital weighing scale with an accuracy to the nearest 0.1 kg
Time frame: 4 and 8 weeks
Fasting plasma glucose in mg/dl
Will be analyzed by enzymatic assays
Time frame: 4 and 8 weeks
Indices of ß-cell function
Will be assessed using the insulinogenic index (IGI)
Time frame: 4 and 8 weeks
ß-cell function assessed by Oral Disposition Index (DI(O))
Will be assessed using the Oral Disposition Index (DI(O))
Time frame: 4 and 8 weeks
ß-cell function assessed by Homeostatic Model Assessment of ß-cell Function (HOMA-B)
Will be assessed using the Homeostatic Model Assessment of ß-cell Function (HOMA-B)
Time frame: 4 and 8 weeks
Indices of hepatic insulin resistance
Will be assessed using the Hepatic Insulin Resistance Index (HIRI)
Time frame: 4 and 8 weeks
Alanine aminotransferase (liver enzyme) in U/L
Will be analyzed with colorimetric assays
Time frame: 4 and 8 weeks