Nutritional intervention to improve brain health and longevity

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

This study is testing if a special diet that mimics fasting can help middle-aged people at risk for Alzheimer's improve their brain health over six months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 45 Years to 65 Years
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06682767 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, feasibility, and efficacy of a six-month fasting-mimicking diet (FMD) intervention in middle-aged adults who are at elevated risk for Alzheimer's disease due to the APOE ε4 allele. Participants will be randomly assigned to either the FMD group, which follows a specific diet for five days each month, or a normal diet group. The study aims to assess cognitive function, blood biomarkers, and brain structure and function through various evaluations, with a follow-up period after the intervention. The design includes blinding for those assessing outcomes to minimize bias.

Who should consider this trial

Good fit: Ideal candidates are middle-aged adults aged 45-65 who carry at least one copy of the APOE e4 allele and have a BMI between 20-39 kg/m2.

Not a fit: Patients with significant neurological conditions or severe mental health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a novel dietary approach to reduce the risk of Alzheimer's disease in at-risk individuals.

How similar studies have performed: While similar dietary interventions have shown promise, this specific fasting-mimicking approach is relatively novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

* 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

Where this trial is running

Los Angeles, California

• Cedars Sinai Medical Center — Los Angeles, California, United States (RECRUITING)

Study contacts

• Principal investigator: Mitzi Gonzales, PhD — Cedars-Sinai Medical Center
• Study coordinator: Mitzi Gonzales, PhD

Conditions: Cerebral Blood Flow, APOE 4, prevention, alzheimer&#39, s disease, nutritition, fasting mimicking diet