Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-06 @ 6:57 AM
Study NCT ID:
NCT06682767
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Nutritional Intervention for Body, Brain, and Longevity Effects (NIBBLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'As diet requires volitional activity, the study participants cannot be blinded. To minimize bias, the investigators evaluating cognitive, research labs, and MRI outcomes will be blinded to group assignments.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-11-07', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Examine the impact of FMD relative to normal diet on ADRD blood-based biomarkers', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'Endpoint: Circulating levels of abeta 40 and 42, phosphorylated tau 217 (p-tau 217), neurofilament light (NFL), and glial fibrillary acidic protein (GFAP). The same unit of measurement applies for all - pg/ml.'}, {'measure': 'Evaluate the efficacy of FMD relative to normal diet for modulating autophagic flux', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'Endpoint: Autophagic flux in PBMCs and tissue (optional) Autophagy related gene expression. Both have the same unit of measurement as arbitrary units.'}, {'measure': 'Evaluate the efficacy of FMD relative to normal diet for modulating metabolic parameters', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'Endpoint: Blood glucose. Unit of measure is mg/dl.'}, {'measure': 'Examine the impact of FMD on systemic markers of inflammation through physiological paramaters.', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'Endpoint: Proteomic expression of pro-inflammatory markers Pro-inflammatory markers are IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, which are all measured in pg/ml.'}, {'measure': 'Evaluate the efficacy of FMD relative to normal diet for modulating metabolic parameters', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'Endpoint: Insulin. Unit of measure is μU/mL.'}, {'measure': 'Evaluate the efficacy of FMD relative to normal diet for modulating metabolic parameters', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'Endpoint: IGF-1 levels. Unit of measure is ng/ml.'}], 'primaryOutcomes': [{'measure': 'Investigate the impact of the FMD intervention on cerebral blood flow relative to normal diet', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'Endpoint: Cerebral blood flow Cerebral blood flow will be assessed through brain magnetic resonance imaging arterial spin labeling sequence.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the safety of a six-month FMD intervention', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'Endpoint: Number of adverse events in the intervention group relative to the placebo group'}, {'measure': 'Investigate the impact of the FMD intervention on cognition relative to normal diet', 'timeFrame': 'From enrollment to end of study (Day 251 +/-7 days)', 'description': 'NIH Toolbox Flanker and Pattern Comparison Tests. These assessments are measured through scaled scores (T-scores), which range from 20-80 with higher scores indicating better outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['APOE 4', 'prevention', 'alzheimer's disease', 'nutritition', 'fasting mimicking diet'], 'conditions': ['Cerebral Blood Flow', 'APOE 4']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Participants assigned to the FMD arm will adhere to the diet for 5 days a month over a period of 6-months. The FMD diet is produced by L-Nutra and provides 1100 kcals on the day 1 and 800 kcals on days 2-5. The diet consists of ingredients which are Generally Regarded As Safe (GRAS) selected for their fasting mimicking properties.\n\nThe overarching hypothesis of the study is that the dietary intervention will be safe and well-tolerated. This is a phase 2 single-site trial with a randomized, open label, parallel assignment design.\n\nTo minimize bias, individuals evaluating the cognitive, research lab, and MRI outcomes will be blinded to the assigned intervention group.\n\nThe study will enroll 60 participants who will be randomized 1:1 to the fasting-mimicking diet (FMD) intervention versus normal diet with stratification for age and sex. The intervention period is 6-months. Study visits 2-7 occur the day after the participant completes five days of FMD for that cycle if assigned to the FMD group. The intervention period if followed by a 3-month observational follow-up period.\n\nThe study design will enable investigations of the efficacy of FMD relative to normal diet for cognition, ADRD blood biomarkers, and brain structure in function in middle-aged adults at elevated risk for Alzheimer's disease due to the APOE e4 genotype. As diet requires volitional activity, the study participants cannot be blinded. To minimize bias, the investigators evaluating cognitive, research labs, and MRI outcomes will be blinded to group assignments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 45-65 years at screening\n4. Carrier of at least one copy of the APOE e4 allele\n5. BMI 20-39kg/m2 (inclusive) at screening\n\nExclusion Criteria:\n\n* 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);\n* Significant depression (PHQ-9 greater than 9) or generalized anxiety (GAD-7 greater than 9)\n* Diagnosis of a significant neurological condition such as multiple sclerosis, epilepsy, Parkinson's disease, major stroke\n* Contraindications to MRI such as claustrophobia, cardiac pacemaker, etc.\n* Current adherence or adherence within the past 3 months to a specialized diet (e.g. ketogenic, paleo, intermittent fasting, raw food, vegan)\n* Food allergies (e.g. dairy, eggs, fish/shellfish, peanuts, tree nuts, soy, wheat, sesame, corn)\n* Diagnosis of mild cognitive impairment or dementia; use of an FDA-approved medication for Alzheimer's disease; MoCA less than 23\n* Diabetes (hbA1c greater than 6.5%) or anti-diabetic medications\n* History of gastric bypass;\n* Inflammatory bowel disease\n* Small or large bowel resection\n* Subjects with recent weight loss (greater than 5%), use of weight loss medication, participated in a weight loss program in the past 3 months\n* Use of immune suppression drugs;\n* Contraindication for study foods (special food needs and allergy);\n* Women who are pregnant, lactating, or trying to conceive\n* Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men)\n* Current smoker or tobacco use within 3 months.\n* Active malignant cancer or history of malignancy within the last 1 years (except non-melanoma skin cancer)\n* Serious psychiatric disorders such as schizophrenia, bipolar disorder, eating disorders\n* Persons with allergy to animal dander or animal-instigated asthma"}, 'identificationModule': {'nctId': 'NCT06682767', 'briefTitle': 'A Nutritional Intervention for Body, Brain, and Longevity Effects (NIBBLE)', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Nutritional Intervention for Body, Brain, and Longevity Effects (NIBBLE) - A Randomized Open-label Intervention of the Fasting-mimicking Diet (FMD)', 'orgStudyIdInfo': {'id': 'STUDY00003359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMD - Intervention', 'description': 'Participants in the FMD group will be asked to refrain from consuming any calorie-containing foods or drinks other than the provided study foods/drinks during the designated intervention days each month.', 'interventionNames': ['Dietary Supplement: FMD1 (LNT22-017-1)']}, {'type': 'NO_INTERVENTION', 'label': 'Normal Diet - Control', 'description': 'Participants in the normal diet group will be asked to consume their regular diet.'}], 'interventions': [{'name': 'FMD1 (LNT22-017-1)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'FMD is a plant-based ketogenic diet that provides essential nutrients while maintaining hypo-caloric content. FMD is administered cyclically with 3-5 consecutive days of the diet followed by resumption of normal eating.', 'armGroupLabels': ['FMD - Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitzi Gonzales, PhD', 'role': 'CONTACT', 'email': 'mitzi.gonzales@cshs.org', 'phone': '424-315-0228'}, {'name': 'Sara Espinoza, MD', 'role': 'CONTACT', 'email': 'sara.espinoza@cshs.org'}], 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Mitzi Gonzales, PhD', 'role': 'CONTACT', 'email': 'mitzi.gonzales@cshs.org', 'phone': '424-315-0228'}, {'name': 'Sara Espinoza, MD', 'role': 'CONTACT', 'email': 'sara.espinoza@cshs.org', 'phone': '210-310-5859'}], 'overallOfficials': [{'name': 'Mitzi Gonzales, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'De-identified data will be available within 6 months of release of the primary endpoint results and will be made available by request indefinitely', 'ipdSharing': 'YES', 'description': 'Data collected for this study will be analyzed and stored at Cedars Sinai. After the study is completed, the de-identified, archived data will be stored at Cedars Sinai for use by other researchers including those outside of the study. As new relevant methodologies are developed, however, there is a conceivable future interest to process deidentified samples and data in a collaborating laboratory at Cedars-Sinai Medical Center or outside of Cedars-Sinai Medical Center including commercial entities. Participants are made aware of this possibility in the written informed consent form at the time of enrollment and are informed that to consent to this study is also to consent to permit coded data to be shared for the purposes of this research. The key to the code is not shared with collaborators but will remain in a HIPAA-compliant, secure, REDCap database at Cedars-Sinai Medical Center.', 'accessCriteria': 'Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mitzi Gonzales', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}