COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study on Fasting-Mimicking Diet in Asian Americans With Prediabetes

Quick Facts

Study Start:2024-08-12
Study Completion:2025-05-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06518798

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Identify as Asian American
  2. * Diagnosed with prediabetes according to at least one of the following:
  3. * HbA1C 5.7%-6.4%
  4. * Fasting blood glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L )
  5. * Oral glucose tolerance test (OGTT) 140-199 mg/dL at two hours
  1. * Individuals with a personal history of diabetes mellitus (ICD-10 codes E08-E13), cardiovascular disease, mental illness, drug dependency, pregnancy, and special dietary restrictions
  2. * Individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin
  3. * Individuals who are pregnant or breastfeeding
  4. * Individuals with anaphylaxis food allergies
  5. * Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
  6. * Individuals who have completed the FMD in the past year

Contacts and Locations

Principal Investigator

Hannah Lui Park, PhD
PRINCIPAL_INVESTIGATOR
University of California, Irvine

Study Locations (Sites)

UC Irvine
Irvine, California, 92617
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Hannah Lui Park, PhD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-12
Study Completion Date2025-05-09

Study Record Updates

Study Start Date2024-08-12
Study Completion Date2025-05-09

Terms related to this study

Additional Relevant MeSH Terms

  • Prediabetes
  • Prediabetic State