Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-02 @ 5:38 AM
Study NCT ID:
NCT03527368
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2018-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Time-Restricted Intake of Meals Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Change', 'timeFrame': '12 weeks', 'description': 'Weight change will be measured in kg'}], 'secondaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': '12 weeks', 'description': 'Change in fasting glucose'}, {'measure': 'HOMA-IR', 'timeFrame': '12 weeks', 'description': 'Change in HOMA-IR'}, {'measure': 'AUC glucose', 'timeFrame': '12 weeks', 'description': 'Area-under-the-curve for glucose on OGTT'}, {'measure': 'Glycated albumin', 'timeFrame': '12 weeks', 'description': 'Glycated albumin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PreDiabetes', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '40241264', 'type': 'DERIVED', 'citation': 'Duan D, Pham LV, Jun JC, Turkson-Ocran RA, Pilla SJ, Clark JM, Maruthur NM. Effects of time-restricted eating on actigraphy-derived sleep parameters: post hoc analysis of a randomized, isocaloric feeding study. Sleep. 2025 Sep 9;48(9):zsaf089. doi: 10.1093/sleep/zsaf089.'}, {'pmid': '38639542', 'type': 'DERIVED', 'citation': 'Maruthur NM, Pilla SJ, White K, Wu B, Maw MTT, Duan D, Turkson-Ocran RA, Zhao D, Charleston J, Peterson CM, Dougherty RJ, Schrack JA, Appel LJ, Guallar E, Clark JM. Effect of Isocaloric, Time-Restricted Eating on Body Weight in Adults With Obesity : A Randomized Controlled Trial. Ann Intern Med. 2024 May;177(5):549-558. doi: 10.7326/M23-3132. Epub 2024 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'TRIM is a randomized, controlled feeding study to evaluate if eating earlier in the day vs. later in the day impacts weight and glucose homeostasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prediabetes defined by HbA1c 5.7-6.4%, or type 2 diabetes with HbA1c 6.5-6.9%\n* Class I-III obesity (BMI 30-50 kg/m2)\n* If on medications for hypertension, stable regimen for at least past 6 months\n* Willingness to adjust timing of feeding\n* Willingness and ability to eat study diet and nothing else during run-in and intervention\n* Willingness to complete measurement procedures\n\nExclusion Criteria:\n\n* Moderate to severe obstructive sleep apnea\n* Shift work;\n* Other sleep/circadian disorders: e.g., circadian phase delay or phase advance; restless legs syndrome, insomnia, narcolepsy, habitual sleep \\<6 hours/night\n* Routinely ate within compressed time window in the past year (e.g., routinely eats all food within an 10-hour or narrower window, follows an intermittent fasting protocol)\n* Renal dysfunction (estimated Glomerular Filtration Rate (GFR) \\<30 using the simplified Chronic Kidney Disease (CKD) Epidemiology Collaboration (EPI) equation 34)\n* Use of glucose-lowering medications, weight loss medications, medications for sleep disorders (sedative/hypnotic drugs, stimulants), lithium, systemic corticosteroids, diuretics, blood thinners requiring regular monitoring (e.g. warfarin), anti-psychotic drugs and antiretroviral therapy\n* Body weight \\>400 pounds (limitation of facility scales)\n* \\>1 drink per day of alcohol\n* Active substance use disorder or significant psychiatric/psychologic disorder that would interfere with participation\n* Significant food allergies, preferences, intolerances, or dietary supplements that would interfere with diet adherence\n* Weight loss or gain of ≥5% during past 6 months\n* Pregnant, planning to become pregnant, or breastfeeding\n* Planning to start a weight loss program\n* Planning to leave the area prior to end of study\n* Current participation in another clinical trial\n* Cancer diagnosis requiring active treatment in past two years or planned treatment (with exception of localized non-melanoma skin cancer)\n* Active inflammatory bowel disease, malabsorption, or history of major gastrointestinal surgery involving bowel resection\n* Myocardial infarction or stroke in past 6 months\n* Prior bariatric surgery\n* Any serious illness that would interfere with participation\n* Other conditions or situations at the discretion of the PI'}, 'identificationModule': {'nctId': 'NCT03527368', 'acronym': 'TRIM', 'briefTitle': 'The Time-Restricted Intake of Meals Study', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'The Time-Restricted Intake of Meals Study: A Randomized, Controlled Feeding Study', 'orgStudyIdInfo': {'id': 'IRB00155640'}, 'secondaryIdInfos': [{'id': '17SFRN33590069', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time-restricted feeding', 'interventionNames': ['Behavioral: Time-restricted feeding']}, {'type': 'OTHER', 'label': 'Usual feeding pattern', 'description': 'Comparison', 'interventionNames': ['Behavioral: Usual feeding pattern']}], 'interventions': [{'name': 'Time-restricted feeding', 'type': 'BEHAVIORAL', 'description': 'Participants consume food earlier in the day', 'armGroupLabels': ['Time-restricted feeding']}, {'name': 'Usual feeding pattern', 'type': 'BEHAVIORAL', 'description': 'Participants consume food later in the day', 'armGroupLabels': ['Usual feeding pattern']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21207', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins ProHealth', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Nisa Maruthur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}