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Behavioral Intervention

Fasting-Mimicking Diet for Prediabetes

N/A
Recruiting
Led By Hannah Lui Park, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Summary

"This trial aims to see if the Fasting-Mimicking Diet can be studied effectively in Asian Americans with prediabetes. They want to know if people will join the study, stick to the diet

Who is the study for?
This trial is for Asian Americans who have prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be type 2 diabetes. Participants should be willing to follow a Fasting-Mimicking Diet (FMD) for 5 days and attend pre- and post-diet study visits.
What is being tested?
The study tests the feasibility of the Fasting-Mimicking Diet in this population and its preliminary effects on fasting blood glucose levels and body measurements. It involves one cycle of FMD over five days with surveys and health checks before and after.
What are the potential side effects?
Potential side effects may include hunger, fatigue, dizziness, or irritability due to calorie restriction. Some individuals might experience changes in bowel habits or discomfort as their body adjusts to the diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with prediabetes based on blood tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking insulin or drugs similar to insulin, or I am taking diabetes medication other than metformin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence rate
Attrition rate
Recruitment rate
+1 more
Secondary study objectives
Change in blood pressure
Change in body mass index
Change in fasting blood glucose levels
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fasting Mimicking Diet (FMD)Experimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Fasting Mimicking Diet
2021
N/A
~60

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
559 Previous Clinical Trials
1,929,978 Total Patients Enrolled
University of Southern CaliforniaOTHER
936 Previous Clinical Trials
1,613,451 Total Patients Enrolled
Hannah Lui Park, PhDPrincipal InvestigatorUniversity of California, Irvine
~20 spots leftby Nov 2024
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