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

Description

The study aims to evaluate the safety, feasibility, and efficacy of six-month fasting-mimicking (FMD) intervention in middle-aged adults at elevated risk for Alzheimer's disease due to the apolipoprotein (APOE) ε4 allele. Participants randomly assigned to the active intervention will consume a FMD for 5-days each month over a period of 6-months.

Conditions

Cerebral Blood Flow, APOE 4

Study Overview

Study Details

Study overview

The study aims to evaluate the safety, feasibility, and efficacy of six-month fasting-mimicking (FMD) intervention in middle-aged adults at elevated risk for Alzheimer's disease due to the apolipoprotein (APOE) ε4 allele. Participants randomly assigned to the active intervention will consume a FMD for 5-days each month over a period of 6-months.

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

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

Condition
Cerebral Blood Flow
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Provision of signed and dated informed consent form
  • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  • 3. Male or female, aged 45-65 years at screening
  • 4. Carrier of at least one copy of the APOE e4 allele
  • 5. BMI 20-39kg/m2 (inclusive) at screening
  • * 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 greater than 9) or generalized anxiety (GAD-7 greater than 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 less than 23
  • * Diabetes (hbA1c greater than 6.5%) or anti-diabetic medications
  • * History of gastric bypass;
  • * Inflammatory bowel disease
  • * Small or large bowel resection
  • * Subjects with recent weight loss (greater than 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 years (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

Ages Eligible for Study

45 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

Mitzi Gonzales, PhD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2026-11