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NCT Number: NCT06518798

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

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Irvine

Irvine, California, 92617, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fasting mimicking diet

Behavioral

Participants will be instructed to follow their usual diet except for 5 days when they eat the foods in the FMD kit. The FMD consists of a blend of 100% plant based nutrients generally regarded as safe. One FMD kit provides for the replacement of the normal diet with plant products for five consecutive days. The formulation of these products was based on studies carried out at the Longevity Institute of the University of Southern California, led by Dr. Valter Longo and his collaborators over several decades of research.

Primary outcomes

  1. Recruitment rate

    Time frame: up to 6 months

    Recruitment rate will be determined based on the number of individuals who consented to be in the pilot Fasting Mimicking Diet trial per month.

  2. Adherence rate

    Time frame: up to 6 months

    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.

  3. Attrition rate

    Time frame: up to 6 months

    Attrition rate will be determined based on the number of individuals who stopped consuming the Fasting Mimicking Diet or never started.

  4. Willingness to participate in a future full Fasting Mimicking Diet (FMD) clinical trial

    Time frame: up to 6 months

    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.

Secondary outcomes

  1. Change in fasting blood glucose levels

    Time frame: Pre v. post 5-day FMD cycle

    Fasting blood glucose levels will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) (using a lancet and glucose meter)

  2. Change in blood pressure

    Time frame: Pre v. post 5-day FMD cycle

    Systolic and diastolic blood pressure will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)

  3. Change in body mass index

    Time frame: Pre v. post 5-day FMD cycle

    Body mass index will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)

  4. Change in percent body/visceral fat

    Time frame: Pre v. post 5-day FMD cycle

    Percent body fat and percent visceral fat will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)

  5. Change in waist circumference

    Time frame: Pre v. post 5-day FMD cycle

    Waist circumference will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)

  6. Change in ketone levels

    Time frame: Pre v. post 5-day FMD cycle

    β-Hydroxybutyrate level will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) using a lancet and blood ketone meter

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • University of Southern California

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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