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

Starting soon · Not applicable

Conditions studied: Cerebral Blood Flow, APOE 4

In brief

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 facts

Study ID: NCT06682767
Run by: Cedars-Sinai Medical Center
People needed: 40
Starts: 2026-03-01
Expected to finish: 2027-03-01
Last updated by the study team: 2026-02-09

Who can join

Age: 45 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men)
Current smoker or tobacco use within 3 months.
Active malignant cancer or history of malignancy within the last 1 yea1s (except non-melanoma skin cancer)
Serious psychiatric disorders such as schizophrenia, bipolar disorder, eating disorders
Persons with allergy to animal dander or animal-instigated asthma

Where it is running

Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.