Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans With Prediabetes
NCT Number: NCT06518798
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prediabetes|Prediabetic State
Interventions: BEHAVIORAL: Fasting Mimicking Diet
Sponsor: University of California, Irvine
Collaborators: University of Southern California
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-12
Completion Date: 2024-12-31
Locations: UC Irvine, Irvine, California, 92617, United States

Summary:
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.

Primary Outcome Measures: Recruitment rate, Recruitment rate will be determined based on the number of individuals who consented to be in the pilot Fasting Mimicking Diet trial per month., up to 6 months|Adherence rate, Study adherence will be assessed based on the participant's changes in fasting blood glucose and blood ketone levels measured pre- vs. post- Fasting Mimicking Diet (FMD); a post-FMD survey asking about adherence to the FMD; and attending the follow-up study appointment. The survey will also ask for participants' feedback on their experiences of the trial, including adverse events, and, if applicable, reasons for non-adherence, to enable further study optimization., up to 6 months|Attrition rate, Attrition rate will be determined based on the number of individuals who stopped consuming the Fasting Mimicking Diet or never started., up to 6 months|Willingness to participate in a future full Fasting Mimicking Diet (FMD) clinical trial, Willingness to participate in a future full FMD clinical trial (which would have 4 FMD cycles + additional study appointments at 4 months after the last FMD cycle) will also be assessed via survey at the conclusion of their participation in this pilot., up to 6 months
Secondary Outcome Measures: Change in fasting blood glucose levels, Fasting blood glucose levels will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) (using a lancet and glucose meter), Pre v. post 5-day FMD cycle|Change in blood pressure, Systolic and diastolic blood pressure will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD), Pre v. post 5-day FMD cycle|Change in body mass index, Body mass index will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD), Pre v. post 5-day FMD cycle|Change in percent body/visceral fat, Percent body fat and percent visceral fat will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD), Pre v. post 5-day FMD cycle|Change in waist circumference, Waist circumference will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD), Pre v. post 5-day FMD cycle|Change in ketone levels, β-Hydroxybutyrate level will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) using a lancet and blood ketone meter, Pre v. post 5-day FMD cycle