A Nutritional Intervention for Body, Brain, and Longevity Effects (NIBBLE)
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 9, 2026
February 1, 2026
1 year
October 29, 2024
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety of a six-month FMD intervention
Endpoint: Number of adverse events in the intervention group relative to the Dietary Guidance group
From pre- to post-treatment (Day 165 +/-8 days)
Secondary Outcomes (2)
Investigate the impact of the FMD intervention on cerebral blood flow relative to the Dietary Guidance Group
From pre- to post-treatment (Day 165 +/-8 days)
Investigate the impact of the FMD intervention on cognition relative to the Dietary Guidance group.
From pre- to post-treatment (Day 165 +/-8 days)
Other Outcomes (7)
Examine the impact of FMD relative to Dietary Guidance on ADRD blood-based biomarkers
From pre- to post-treatment (Day 165 +/-8 days)
Evaluate the efficacy of FMD relative to Dietary Guidance for modulating autophagic flux
From pre- to post-treatment (Day 165 +/-8 days)
Evaluate the efficacy of FMD relative to Dietary Guidance for modulating insulin growth factor-1
From pre- to post-treatment (Day 165 +/-8 days)
- +4 more other outcomes
Study Arms (2)
FMD - Intervention
EXPERIMENTALParticipants 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.
Dietary Guidance
ACTIVE COMPARATORThe Dietary Guidance Group will receive nutrition recommendations based on the Harvard Healthy Eating Plate.
Interventions
Participants will receive established dietary guidance based on the Harvard Healthy Eating Plate.
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.
Eligibility Criteria
You may qualify if:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 45-65 years at screening
- Carrier of at least one copy of the APOE e4 allele
- BMI 20-39kg/m2 (inclusive) at screening
- On a stable medication regimen for at least 3 months.
You may not qualify if:
- Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation\* (\*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial);
- Significant depression (PHQ-9\>9) or generalized anxiety (GAD-7\>9)
- Diagnosis of a significant neurological condition such as multiple sclerosis, epilepsy, Parkinson's disease, major stroke
- Contraindications to MRI such as claustrophobia, cardiac pacemaker, etc.
- Current adherence or adherence within the past 3 months to a specialized diet (e.g. ketogenic, paleo, intermittent fasting, raw food, vegan)
- Food allergies (e.g. dairy, eggs, fish/shellfish, peanuts, tree nuts, soy, wheat, sesame, corn)
- Diagnosis of mild cognitive impairment or dementia; use of an FDA-approved medication for Alzheimer's disease; MoCA\<23
- Diabetes (hbA1c \>6.5%) or anti-diabetic medications
- History of gastric bypass;
- Inflammatory bowel disease
- Small or large bowel resection
- Subjects with recent weight loss (\>5%), use of weight loss medication, participated in a weight loss program in the past 3 months
- Use of immune suppression drugs;
- Contraindication for study foods (special food needs and allergy);
- Women who are pregnant, lactating, or trying to conceive
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitzi Gonzales, PhD
Cedars-Sinai Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 29, 2024
First Posted
November 12, 2024
Study Start
March 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- De-identified data will be available within 6 months of release of the primary endpoint results and will be made available by request indefinitely
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA)
Data collected for this study will be analyzed and stored at Cedars Sinai. After the study is completed, the de-identified, archived data will be stored at Cedars Sinai for use by other researchers including those outside of the study. As new relevant methodologies are developed, however, there is a conceivable future interest to process deidentified samples and data in a collaborating laboratory at Cedars-Sinai Medical Center or outside of Cedars-Sinai Medical Center including commercial entities. Participants are made aware of this possibility in the written informed consent form at the time of enrollment and are informed that to consent to this study is also to consent to permit coded data to be shared for the purposes of this research. The key to the code is not shared with collaborators but will remain in a HIPAA-compliant, secure, REDCap database at Cedars-Sinai Medical Center.