Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans with Prediabetes
Purpose
This is a pilot study to determine the feasibility of studying the Fasting-Mimicking Diet (FMD), a dietary approach that involves the consumption of a specifically formulated, calorie-restricted nutrition regimen with a customized macronutrient composition, ratio, and quantity over a 5- day period, on a larger scale in Asian Americans with prediabetes and to examine the preliminary effects of the diet in study participants. The main questions the study aims to answer are: 1. What are the recruitment, adherence, and attrition rates of eligible participants into the study? 2. Does one FMD cycle result in changes in fasting blood glucose levels and physical measurements in study participants? Participants will be asked to undergo one cycle of FMD (for 5 days), fill out surveys, and come in for a pre-FMD and post-FMD study visit, during which physical measurements and fasting blood glucose and ketone levels will be measured.
Conditions
- Prediabetes
- Prediabetic State
Eligibility
- Eligible Ages
- Between 30 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Identify as Asian American - Diagnosed with prediabetes according to at least one of the following: - HbA1C 5.7%-6.4% - Fasting blood glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L ) - Oral glucose tolerance test (OGTT) 140-199 mg/dL at two hours
Exclusion Criteria
- Individuals with a personal history of diabetes mellitus (ICD-10 codes E08-E13), cardiovascular disease, mental illness, drug dependency, pregnancy, and special dietary restrictions - Individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin - Individuals who are pregnant or breastfeeding - Individuals with anaphylaxis food allergies - Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac - Individuals who have completed the FMD in the past year
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Fasting Mimicking Diet (FMD) |
The fasting-mimicking diet (FMD) group will be instructed on the benefits and use of the FMD kit. Participants will be given one 5-day FMD kit at their baseline visit. They will be instructed to follow the kit, and only eat its items, for five consecutive days and to report back for a follow-up visit and measurements at the end of their 5 days before returning to their normal diet. |
|
Recruiting Locations
Irvine, California 92617
More Details
- NCT ID
- NCT06518798
- Status
- Recruiting
- Sponsor
- University of California, Irvine