RECRUITING

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

Conditions

Cerebral Blood Flow APOE 4 prevention alzheimer's disease nutritition fasting mimicking diet

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06682767

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.

Ages Eligible for Study:45 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Mitzi Gonzales, PhD

CONTACT

424-315-0228

mitzi.gonzales@cshs.org

Sara Espinoza, MD

CONTACT

210-310-5859

sara.espinoza@cshs.org

Principal Investigator

Mitzi Gonzales, PhD

PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-11

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

APOE 4
prevention
alzheimer's disease
nutritition
fasting mimicking diet

Additional Relevant MeSH Terms

Cerebral Blood Flow
APOE 4