Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-03-14 @ 4:03 AM
Study NCT ID:
NCT06259435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulating Energy Density in Time-Restricted Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Subjects will be randomly assigned to one of two groups. Except for the Director of the Metabolic Kitchen and the dietitians assigned to the study, all other researchers conducting the study will be blinded to the treatment group assignment of subjects.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomly assigned to receive a diet low in energy density or the usual diet.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Insulin Resistance', 'timeFrame': '8 weeks', 'description': 'Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes'}, {'measure': 'Ketones', 'timeFrame': '8 weeks', 'description': 'Ketones'}, {'measure': 'Body weight', 'timeFrame': '8 weeks', 'description': 'Body weight'}, {'measure': 'Peripheral insulin resistance', 'timeFrame': '8 weeks', 'description': 'Homeostasis model assessment of insulin resistance (HOMA-IR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance', 'Body Weight']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet (reduced calories per gram of food) in older adults with obesity and insulin resistance. The study aims to determine if modulating the energy density of the diet reduces:\n\n1. Insulin resistance and\n2. Body weight.\n\nResearchers will compare the groups:\n\n1. Following time-restricted eating and given a diet reduced in energy density or\n2. Following time-restricted eating and given a diet typically consumed in this population', 'detailedDescription': 'The study is an eight-week randomized controlled double-blinded clinical trial. Participants will follow time-restricted eating (14-hour fast, 10-hour eating window), and will be randomized to a diet low in energy density or the usual diet. Meals will be prepared in a metabolic kitchen and dispensed to participants. Dietitians will monitor dietary compliance. A blood sample will be drawn and body weight will be measured before starting the intervention and after completing it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body mass index (BMI) ≥ 30kg/m2.\n2. Mini-Mental State Examination (MMSE) \\> 25\n3. Geriatric Depression Scale-15 (GDS-15) \\< 9\n4. Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3.\n\nExclusion Criteria:\n\n1. Diagnosis of Type 2 diabetes received more than five years ago\n2. Diagnosis of type 1 diabetes\n3. Evidence of clinically significant renal dysfunction or disease\n4. History of malignancy during the past five years\n5. Being treated with systemic steroids, olanzapine, or clozapine\n6. Being treated with prescription medications for obesity\n7. Being treated with thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin\n8. Weight change \\> 3 kg in the preceding three months\n9. Any disease or condition that precludes testing of the study outcomes or makes it unsafe to consume the foods being tested in the study, or subjects are otherwise deemed to be unsuitable for participation in the study (determined by the investigative team)'}, 'identificationModule': {'nctId': 'NCT06259435', 'acronym': 'MEDITRE', 'briefTitle': 'Modulating Energy Density in Time-Restricted Eating', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Modulating Energy Density in Time-Restricted Eating', 'orgStudyIdInfo': {'id': 'PBRC-2023-049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low energy dense diet', 'description': 'Subjects will be required to follow time-restricted eating and receive a diet low in energy density', 'interventionNames': ['Behavioral: Low-energy dense diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual diet', 'description': 'Subjects will be required to follow time-restricted eating and receive the usual diet.', 'interventionNames': ['Behavioral: Usual diet']}], 'interventions': [{'name': 'Low-energy dense diet', 'type': 'BEHAVIORAL', 'description': 'Subjects will follow time-restricted eating of a low energy dense diet', 'armGroupLabels': ['Low energy dense diet']}, {'name': 'Usual diet', 'type': 'BEHAVIORAL', 'description': 'Subjects will follow time-restricted eating of the usual diet', 'armGroupLabels': ['Usual diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Candida Rebello', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Candida Rebello', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}