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

University of California, Irvine30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prediabetes Prediabetic State

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: up to 6 months

Secondary Outcomes

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)