Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans With Prediabetes

Completed · Not applicable

Conditions studied: Prediabetes, Prediabetic State

In brief

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.

Key facts

Study ID

NCT06518798

Run by

University of California, Irvine

People needed

30

Starts

2024-08-12

Expected to finish

2025-05-09

Last updated by the study team

2025-09-30

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Irvine — Irvine, California, United States

Full record on ClinicalTrials.gov

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