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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT06682767
Status
Not Yet Recruiting

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Conditions

  • APOE 4
  • Cerebral Blood Flow

Eligibility Criteria

Sex
ALL
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • FMD1 (LNT22-017-1) — DIETARY_SUPPLEMENT
    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.
  • Dietary Guidance — BEHAVIORAL
    Participants will receive established dietary guidance based on the Harvard Healthy Eating Plate.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: FMD - Intervention
    Participants in the FMD group will be asked to refrain from consuming any calorie-containing foods or drinks other than the provided study foods/drinks during the designated intervention days each month.
  • Active Comparator: Dietary Guidance
    The Dietary Guidance Group will receive nutrition recommendations based on the Harvard Healthy Eating Plate.

Primary Outcome Measure

Evaluate the safety of a six-month FMD intervention [ Time Frame: From pre- to post-treatment (Day 165 +/-8 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Mitzi Gonzales, PhD
[email protected]
424-315-0228
Sara Espinoza, MD
[email protected]

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By research site
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