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Registry update — unassessed

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)

Trial registry update: NOT_YET_RECRUITING. No results reported in the supplied registry record.

RCTRoutine significance
Reporter brief

What this changes

The finding has not established an approved change to our evidence assessment.

Source date: Sep 16, 2026 · Discovered: Sep 16, 2026 · Assessed: — · Research update

What it does not prove

  • The open-label design (participants knew their group assignment) limits evidence for efficacy, as expectations could influence self-reported outcomes
  • No effect sizes or efficacy data are reported, so the magnitude of any benefit or harm is unknown
  • Results in APOE4 carriers may not generalize to the broader population, and no long-term outcomes beyond 8 weeks are assessed

Extracted from supplied source material; model confidence is not a measured probability of correctness.

Design
Rct
Sample size
—
Duration
2 months
Population
Middle-aged adults at elevated risk for Alzheimer's disease due to the apolipoprotein (APOE) ε4 allele
Primary outcome
Safety, feasibility, and preliminary efficacy
Effect size
—
Significance
Not reported
Journal
Cedars-Sinai Medical Center
Published
Sep 16, 2026

Recorded source passages

Abstract or registry material supplied for assessment; source version 2. This is not a claim of full-text review.

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.

Source versions

Version 2: Unassessed

Version 1: Superseded

Assessment history

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