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

Launched by CEDARS-SINAI MEDICAL CENTER · Nov 7, 2024

Keywords

ClinConnect Summary

The NIBBLE trial is studying the effects of a special diet called a fasting-mimicking diet (FMD) on brain health and overall wellness in middle-aged adults at risk for Alzheimer's disease. This risk is linked to a specific gene called APOE ε4. If you join the study, you will follow the FMD for five days each month over a six-month period. The goal is to see if this diet is safe and if it helps improve blood flow to the brain, which is important for brain function.

To be eligible for this study, you need to be between 45 and 65 years old, carry at least one copy of the APOE ε4 gene, and have a body mass index (BMI) between 20 and 39, which is a measure of weight in relation to height. Participants should also be willing to commit to the study procedures and have no significant medical issues or mental health conditions that could interfere with the trial. If you decide to participate, you will be contributing to important research that could help understand how nutrition impacts brain health and longevity.

Gender

ALL

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