NCT06682767

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants assigned to the FMD arm will adhere to the diet for 5 days a month over a period of 6-months. The FMD diet is produced by L-Nutra and provides 1100 kcals on the day 1 and 800 kcals on days 2-5. The diet consists of ingredients which are Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties. The Dietary Guidance Group will receive recommendations based on the Harvard Healthy Eating Plate. The overarching hypothesis of the study is that FMD relative to dietary guidance will be safe and well-tolerated. It is also hypothesized that FMD will be associated with increases in cerebral blood flow. . This is a phase 2 single-site trial with a randomized, open label, parallel assignment design. To minimize bias, individuals evaluating the cognitive, research lab, and MRI outcomes will be blinded to the assigned intervention group. The study will enroll 40 participants who will be randomized 1:1 to the fasting-mimicking diet (FMD) intervention versus the Dietary Guidance group with stratification for age and sex. The intervention period is 6-months. Study visits 2-7 occur the day after the participant completes five days of FMD for that cycle if assigned to the FMD group. Visits 2, 3, 5, and 6 will be completed via phone or secure video platform. The intervention period is followed by a 3-month observational follow-up period for both groups. The study design will enable preliminary investigations of the efficacy of FMD relative to the Dietary Guidance group for cognition, ADRD blood biomarkers, epigenetic clock, and brain structure in function in middle-aged adults at elevated risk for Alzheimer's disease due to the APOE e4 genotype. As diet requires volitional activity, the study participants cannot be blinded. To minimize bias, the investigators evaluating cognitive, research labs, and MRI outcomes will be blinded to group assignments.

Conditions

• Cerebral Blood Flow
• APOE 4

Interventions

Type	Name	Description
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.
BEHAVIORAL	Dietary Guidance	Participants will receive established dietary guidance based on the Harvard Healthy Eating Plate.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-11-12
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States