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

University of California Irvine (UCI)

Status: Enrolling

Conditions: Prediabetes; Prediabetic State

Treatments: Behavioral: Fasting Mimicking Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06518798

4223

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Fasting Mimicking Diet (FMD)

Experimental group

Description:

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.

Treatment:

Behavioral: Fasting Mimicking Diet