Not Yet RecruitingNot Applicable

A Nutritional Intervention for Body, Brain, and Longevity Effects (NIBBLE)

United States40 participantsStarted 2026-03

Plain-language summary

The study aims to evaluate the safety, feasibility, and preliminary efficacy of six-month fasting-mimicking (FMD) relative to Dietary Guidance intervention in middle-aged adults at elevated risk for Alzheimer's disease due to the apolipoprotein (APOE) ε4 allele. Participants randomly assigned to the FMD intervention will consume a FMD for 5-days each month over a period of 6-months.

Who can participate

Age range45 Years – 65 Years

SexALL

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Inclusion criteria

✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male or female, aged 45-65 years at screening
✓. Carrier of at least one copy of the APOE e4 allele
✓. BMI 20-39kg/m2 (inclusive) at screening
✓. On a stable medication regimen for at least 3 months.

What they're measuring

Evaluate the safety of a six-month FMD intervention

Timeframe: From pre- to post-treatment (Day 165 +/-8 days)

Trial details

NCT IDNCT06682767

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Mitzi Gonzales, PhD

424-315-0228 mitzi.gonzales@cshs.org

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