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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Enrolling

Conditions

Prediabetes
Prediabetic State

Treatments

Behavioral: Fasting Mimicking Diet

Study type

Interventional

Funder types

Other

Identifiers

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

Trial contacts and locations

1

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Central trial contact

Mirian Kang

Data sourced from clinicaltrials.gov

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