Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT05290233
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2022-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Time Restricted Eating Plus Exercise for Weight Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014198', 'term': 'Trehalase'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004186', 'term': 'Disaccharidases'}, {'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'blood sample analysis will be blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A 12-week randomized, parallel-arm pilot trial will compare the effects of 1) TRE combined with resistance training (TRE-RT) to 2) TRE combined with aerobic training (TRE-AT) in older adults with overweight or obesity and pre-diabetes'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lean mass', 'timeFrame': 'change from week 1 to week 12', 'description': 'fat free mass will be measured via DXA'}], 'secondaryOutcomes': [{'measure': 'body weight', 'timeFrame': 'change kg of body weight from week 1 to week 12', 'description': 'Body weight assessed to the nearest 0.25 kg every week without shoes and in light clothing using a balance beam scale (HealthOMeter, Boca Raton, FL).'}, {'measure': 'fat mass', 'timeFrame': 'change kg of body weight from week 1 to week 12', 'description': 'fat mass will be measured via DXA'}, {'measure': 'Visceral fat mass', 'timeFrame': 'change kg of body weight from week 1 to week 12', 'description': 'visceral fat mass will be measured via DXA'}, {'measure': 'Insulin', 'timeFrame': 'change from week 1 to week 12', 'description': 'measured by enzymatic kit (uIU/ml)\\^4'}, {'measure': 'glucose', 'timeFrame': 'change from week 1 to week 12', 'description': 'measured by enzymatic kit (mg/dl)'}, {'measure': 'HbA1c', 'timeFrame': 'change from week 1 to week 12', 'description': 'measured by enzymatic kit (mmol/mol)'}, {'measure': 'Attention', 'timeFrame': 'Change from week 1 to week 12', 'description': 'National Institutes of Health Toolbox Cognition Battery'}, {'measure': 'executive function', 'timeFrame': 'Change from week 1 to week 12', 'description': 'National Institutes of Health Toolbox Cognition Battery'}, {'measure': 'processing speed', 'timeFrame': 'Change from week 1 to week 12', 'description': 'National Institutes of Health Toolbox Cognition Battery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intermittent Fasting', 'Pre Diabetes', 'Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'Time restricted eating (TRE) is currently the most popular form of intermittent fasting which involves confining the eating window to 8-10 hours (h) and fasting for the remaining hours of the day. TRE is unique in that during the eating window, individuals are not required to count calories or monitor food intake in any way, resulting in high adherence. Accumulating evidence suggests that TRE produces a natural energy deficit of \\~350-500 kcal/d. Physical activity in combination with a healthy diet pattern is recommended for older adults. While aerobic type exercise is the most commonly recommended, retention of lean mass via resistance training, especially in older adults, may be more effective at improving mobility, neurological and psychological function, executive and cognitive functioning, and processing speed. TRE combined with physical activity has not been examined in older adults or in people with overweight or obesity. This study holds the potential to 1) decrease body weight 2) improve lean mass 3) improve insulin sensitivity, and 4) improve attention, executive functioning, and processing speed in older adults. The aims of this study will examine the effect of TRE combined with either resistance training or aerobic training on body weight, body composition, metabolic disease risk, and cognition in adults over age 50. It is hypothesized that the TRE combined with resistance training group will see the most significant improvements in body composition, insulin sensitivity and cognition due to lean mass accretion.', 'detailedDescription': 'Time restricted eating (TRE) is currently the most popular form of intermittent fasting which involves confining the eating window to 8-10 hours (h) and fasting for the remaining hours of the day. TRE is unique in that during the eating window, individuals are not required to count calories or monitor food intake in any way, resulting in high adherence. Accumulating evidence suggests that TRE produces a natural energy deficit of \\~350-500 kcal/d. Physical activity in combination with a healthy diet pattern is recommended for older adults. While aerobic type exercise is the most commonly recommended, retention of lean mass via resistance training, especially in older adults, may be more effective at improving mobility, neurological and psychological function, executive and cognitive functioning, and processing speed. T TRE combined with physical activity has not been examined in older adults or in people with overweight or obesity. This study holds the potential to 1) decrease body weight 2) improve lean mass 3) improve insulin sensitivity, and 4) improve attention, executive functioning, and processing speed in older adults. This study will examine the effect of TRE combined with either resistance training or aerobic training on body weight, body composition, metabolic disease risk, and cognition in adults over age 50. It is hypothesized that the TRE combined with resistance training group will see the most significant improvements in body composition, insulin sensitivity and cognition due to lean mass accretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with obesity (BMI between 30-50kg/m2)\n* pre-diabetes (fasting glucose: 100-125 mg/dl or HBA1c 5.7%-6.4% or OGTT ≥ 200 mg/dl)\n* sedentary or lightly active (\\<7,500 steps/day)\n* between the ages of 50-80 years\n\nExclusion Criteria:\n\n* diagnosed with T1DM or T2DM (fasting glucose: \\>126 mg/dl, 2-h glucose OGTT ≥ 200 mg/dl,\n* HbA1c: \\>6.5%)\n* Individuals with a history of eating disorders\n* shift workers\n* Individuals taking drugs to control body weight and glucose (including metformin)\n* individuals who are not weight stable (weight gain or loss \\> 4 kg) 3 months prior to the intervention\n* mobility disorders or individuals unable to exercise for 40-60 minutes 3-4 days/week\n* Individuals diagnosed with comorbidities impacting cognition, including major/mild neurocognitive disorder, cerebrovascular disease (e.g., stroke, aneurysm, arteriovenous malformation), traumatic brain injury, epilepsy, or major psychiatric disorder (e.g., schizophrenia, bipolar disorder, substance use disorder)\n* Individuals who are unable to adequately report dietary intake or physical activity\n* Smokers'}, 'identificationModule': {'nctId': 'NCT05290233', 'briefTitle': 'Time Restricted Eating Plus Exercise for Weight Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Time Restricted Eating Plus Exercise for Weight Management', 'orgStudyIdInfo': {'id': '2022-0279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRE+RT', 'description': 'Participants will confine eating between either 10am-6pm or 12-8pm and fast from 6pm-10am or 8pm-12pm daily combined with 3-4 days of supervised resistance training per week.', 'interventionNames': ['Behavioral: TRE + Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRE+AT', 'description': 'Participants will confine eating between either 10am-6pm or 12-8pm and fast from 6pm-10am or 8pm-12pm daily combined with 3-4 days of supervised aerobic training per week.', 'interventionNames': ['Behavioral: TRE + Exercise']}], 'interventions': [{'name': 'TRE + Exercise', 'type': 'BEHAVIORAL', 'description': 'We will compare the effects of TRE combined with resistance exercise versus TRE combined with aerobic training.\n\nOther Names:\n\nresistance training endurance exercise', 'armGroupLabels': ['TRE+AT', 'TRE+RT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor and Postdoctoral Researcher', 'investigatorFullName': 'Kelsey Nicole Dipman Gabel', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}