Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-06 @ 11:34 AM
Study NCT ID:
NCT06115551
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2023-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fasting Mimicking Diet and Autophagy
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']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2023-10-29', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autophagy flux', 'timeFrame': 'Baseline to day 8', 'description': 'PBMCs will be prepared with or without Chloroquine (autophagy flux inhibitor). LC3BI to LC3BII conversion, the lipidation of MAP1LC3B/LC3B (microtubule-associated protein 1 light chain 3 β), in the PBMCs will be accessed by western blot.\n\nAutophagy-dependent degradation of SQSTM1/p62, a receptor and scaffold protein interacting with LC3 and ubiquitinated proteins, will be accessed by western blot.'}], 'secondaryOutcomes': [{'measure': 'Metabolomic change', 'timeFrame': 'Baseline to day 8', 'description': 'Plasma will be analyzed by high throughput RNA sequencing for gene expression changes.'}, {'measure': 'Autophagy-related gene expression', 'timeFrame': 'Baseline to day 8', 'description': 'PBMCs will be prepared with or without Chloroquine (autophagy flux inhibitor). PBMC RNA samples will be analyzed using ultra high-performance liquid chromatography/tandem accurate mass spectrometry (UHPLC/MS/MS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fasting mimicking diet'], 'conditions': ['Diet', 'Autophagy']}, 'referencesModule': {'references': [{'pmid': '41372565', 'type': 'DERIVED', 'citation': 'Espinoza SE, Park S, Connolly G, Qi W, Zhang N, Semwal M, Li Y, Lauzon M, Salmon AB, Hsu W, Wei M, Musi N. Effect of fasting-mimicking diet on markers of autophagy and metabolic health in human subjects. Geroscience. 2025 Dec 11. doi: 10.1007/s11357-025-02035-4. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen.', 'detailedDescription': 'Fasting-mimicking diet (FMD) was developed to mimic the endocrine and metabolic effects that water-only fasting, while providing a modest calories and essential nutrients. The health benefits of FMD are caused by several molecular mechanisms, including the reduction of body weight, ectopic fat storage, insulin levels, endogenous glucose production and IGF-1. Autophagy is a catabolic membrane-trafficking phenomenon observed in yeast and mammalian cells. Nutrient deprivation induces autophagy. Autophagy has been proposed to be a fundamental cellular process being linked to aging and the progression of age-related diseases. The objective of this study is to evaluate the effects of consuming two FMD formulations on the autophagy process in the cell.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability and willingness to provide written informed consent;\n* Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);\n* BMI 20-35 kg/m2 (inclusive) at screening;\n\nExclusion Criteria:\n\n* Diabetes treatment other than diet or metformin monotherapy;\n* History of gastric bypass;\n* Subjects with recent weight loss (\\>5%), use of weight loss medication, participated in a weight loss program in the past 3 months;\n* Type 1 diabetes (based on medical history provided at screening);\n* Use of immune suppression drugs;\n* Contraindication for study foods (special food needs and allergy);\n* Women who are pregnant;\n* Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).\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);"}, 'identificationModule': {'nctId': 'NCT06115551', 'briefTitle': 'Fasting Mimicking Diet and Autophagy', 'organization': {'class': 'INDUSTRY', 'fullName': 'L-Nutra Inc'}, 'officialTitle': 'Cellular Effects of Fasting Mimicking Diet In Humans: An Interventional, Randomized, Open Label, Parallel Assignment Study', 'orgStudyIdInfo': {'id': 'LNT22-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects in the control group will be asked to keep their normal diet during the study period.'}, {'type': 'EXPERIMENTAL', 'label': 'FMD1-ProLon', 'description': 'Subjects in FMD1 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProLonTM).', 'interventionNames': ['Combination Product: Fasting Mimicking Diet']}, {'type': 'EXPERIMENTAL', 'label': 'FMD2-ProMete', 'description': 'Subjects in FMD2 groups will be provided and asked to consume a 5-day low calorie fasting-mimicking diet (ProMeteTM).', 'interventionNames': ['Combination Product: Fasting Mimicking Diet']}], 'interventions': [{'name': 'Fasting Mimicking Diet', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['ProLon, ProMete'], 'description': 'FMD is a 5-day low calorie fasting-mimicking diet.', 'armGroupLabels': ['FMD1-ProLon', 'FMD2-ProMete']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Sara Espinoza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'L-Nutra Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}