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NOT YET RECRUITING
NCT06682767
PHASE1/PHASE2

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

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

Summary

The study aims to evaluate the safety, feasibility, and preliminary efficacy of the fasting-mimicking diet (FMD) or low-dose daily rapamycin treatment relative to a matched placebo control group when administered over 8 weeks 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 adhere to FMD for 5-days over three cycles for a period of approximately 8 weeks. Participants randomly assigned to the rapamycin and placebo groups will take 1 mg of rapamycin or a matched placebo pill daily for approximately 8 weeks.

Official title: A Nutritional and Pharmacological Intervention for Body, Brain, and Longevity Effects (NIBBLE) - A Randomized Open-label Intervention of the Fasting-mimicking Diet (FMD) and Rapamycin (NIBBLE)

Key Details

Gender

All

Age Range

45 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-11

Completion Date

2028-06

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

FMD1 (LNT22-017-1)

FMD is a plant-based ketogenic diet that provides essential nutrients while maintaining hypo-caloric content. FMD is administered cyclically with 3-5 consecutive days of the diet followed by resumption of normal eating.

DRUG

Rapamycin

Participants randomly assigned to the rapamycin arm will take 1 mg of rapamycin daily for approximately 8 weeks..

DRUG

Placebo

Participants randomly assigned to the placebo arm will take one placebo pill daily for approximately 8 weeks.

Locations (1)

Cedars Sinai Medical Center

Los Angeles, California, United States