Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025P012671 | Other Identifier | Emory IRB |
Not provided
Not provided
Not provided
Due to operational issues
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Routine dietary and physical activity habits | Active Comparator | Control participants are asked to maintain their routine dietary and physical activity habits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight in kg | Weight will be measured using a digital weighing scale with an accuracy to the nearest 0.1 kg | 4 and 8 weeks |
| Fasting plasma glucose in mg/dl | Will be analyzed by enzymatic assays |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sathish Thirunavukkarasu, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs) | Atlanta | Georgia | 30322 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
Not provided
Not provided
Not provided
Not provided
Not provided
Nursing staff conducting outcome assessments and laboratory personnel will be blinded to participants' treatment status.
|
|
| 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. |
|
| 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 |
| 4 and 8 weeks |
| Indices of ß-cell function | Will be assessed using the insulinogenic index (IGI) | 4 and 8 weeks |
| ß-cell function assessed by Oral Disposition Index (DI(O)) | Will be assessed using the Oral Disposition Index (DI(O)) | 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) | 4 and 8 weeks |
| Indices of hepatic insulin resistance | Will be assessed using the Hepatic Insulin Resistance Index (HIRI) | 4 and 8 weeks |
| Alanine aminotransferase (liver enzyme) in U/L | Will be analyzed with colorimetric assays | 4 and 8 weeks |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |