Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans with Prediabetes
- Conditions
- PrediabetesPrediabetic State
- Interventions
- Behavioral: Fasting Mimicking Diet
- Registration Number
- NCT06518798
- Lead Sponsor
- University of California, Irvine
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fasting Mimicking Diet (FMD) Fasting Mimicking Diet 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.
- Primary Outcome Measures
Name Time Method Recruitment rate up to 6 months Recruitment rate will be determined based on the number of individuals who consented to be in the pilot Fasting Mimicking Diet trial per month.
Willingness to participate in a future full Fasting Mimicking Diet (FMD) clinical trial up to 6 months 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.
Adherence rate up to 6 months 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.
Attrition rate up to 6 months Attrition rate will be determined based on the number of individuals who stopped consuming the Fasting Mimicking Diet or never started.
- Secondary Outcome Measures
Name Time Method Change in fasting blood glucose levels Pre v. post 5-day FMD cycle Fasting blood glucose levels will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) (using a lancet and glucose meter)
Change in percent body/visceral fat Pre v. post 5-day FMD cycle Percent body fat and percent visceral fat will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
Change in blood pressure Pre v. post 5-day FMD cycle Systolic and diastolic blood pressure will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
Change in body mass index Pre v. post 5-day FMD cycle Body mass index will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
Change in waist circumference Pre v. post 5-day FMD cycle Waist circumference will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
Change in ketone levels Pre v. post 5-day FMD cycle β-Hydroxybutyrate level will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) using a lancet and blood ketone meter
Trial Locations
- Locations (1)
UC Irvine
🇺🇸Irvine, California, United States