Prediabetes, Prediabetic State
Conditions
Brief summary
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.
Interventions
BEHAVIORALFasting Mimicking Diet
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.
Sponsors
University of Southern California
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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. |
| Adherence rate | 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. |
| Attrition rate | 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. |
| Willingness to participate in a future full Fasting Mimicking Diet (FMD) clinical trial | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | Pre v. post 5-day FMD cycle | Waist circumference will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) |
| Change in fasting blood glucose levels | 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) |
| Change in ketone levels | 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 |
| Change in blood pressure | 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) |
| Change in body mass index | Pre v. post 5-day FMD cycle | Body mass index will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) |
| Change in percent body/visceral fat | 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) |
Countries
United States
Outcome results
None listed