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

Description

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

Study Overview

Study Details

Study overview

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.

Pilot Study on Fasting-Mimicking Diet in Asian Americans With Prediabetes

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

Condition
Prediabetes
Intervention / Treatment

-

Contacts and Locations

Irvine

UC Irvine, Irvine, California, United States, 92617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

30 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Irvine,

Hannah Lui Park, PhD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

Study Record Dates

2024-12-31