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A Nutritional and Pharmacological Intervention for Body, Brain, and Longevity Effects (NIBBLE)
Sponsor: Cedars-Sinai Medical Center
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
Conditions
Interventions
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.
Rapamycin
Participants randomly assigned to the rapamycin arm will take 1 mg of rapamycin daily for approximately 8 weeks..
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