Clinical trial NCT06518798: Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans with Prediabetes
Official title: Pilot Study on Fasting-Mimicking Diet in Asian Americans with Prediabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes
Prediabetic State
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2024-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: up to 6 months
measure: Adherence rate
timeFrame: up to 6 months
measure: Attrition rate
timeFrame: up to 6 months
measure: Willingness to participate in a future full Fasting Mimicking Diet (FMD) clinical trial
timeFrame: up to 6 months
Secondary outcomes:
measure: Change in fasting blood glucose levels
timeFrame: Pre v. post 5-day FMD cycle
measure: Change in blood pressure
timeFrame: Pre v. post 5-day FMD cycle
measure: Change in body mass index
timeFrame: Pre v. post 5-day FMD cycle
measure: Change in percent body/visceral fat
timeFrame: Pre v. post 5-day FMD cycle
measure: Change in waist circumference
timeFrame: Pre v. post 5-day FMD cycle
measure: Change in ketone levels
timeFrame: Pre v. post 5-day FMD cycle
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Hannah Lui Park, PhD
role: PRINCIPAL_INVESTIGATOR
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