Status:
COMPLETED
Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans With Prediabetes
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
University of Southern California
Conditions:
Prediabetes
Prediabetic State
Eligibility:
All Genders
30-65 years
Phase:
NA
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 nutri...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06518798
Start Date
August 12 2024
End Date
May 9 2025
Last Update
September 30 2025
Active Locations (1)
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1
UC Irvine
Irvine, California, United States, 92617