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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met