Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 1:53 PM
Study NCT ID:
NCT04138303
Status:
COMPLETED
Last Update Posted:
2020-01-07
First Post:
2019-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Nutrition on Obese Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-03', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2019-10-22', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fecal microbiota diversity', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation'}, {'measure': 'Change in Bacteriodetes/Firmicutes ratio', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation'}, {'measure': 'Percent change in fecal microbiota composition', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation'}, {'measure': 'Change in inflammatory markers', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-α and liposaccharide (LPS) evaluated in pg/ml.'}, {'measure': 'Change in leptin/adiponectin ratio', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in serum adipose markers assessed as change in leptin/adiponectin ratio.'}, {'measure': 'Correlation of serum triglycerides with leptin levels', 'timeFrame': 'Baseline, 9 weeks', 'description': 'The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.'}, {'measure': 'Change in body weight', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in body composition as evaluated as change in body weight measured in lbs.'}, {'measure': 'Change in resting metabolic rate', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.'}, {'measure': 'Change in body composition', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in body composition as evaluated as change in body fat and lean body mass percentage'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in waist circumference measured in inches.'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in blood pressure assessed as systolic and diastolic pressure in mmHg.'}, {'measure': 'Change in visceral fat', 'timeFrame': 'Baseline, 9 weeks', 'description': 'Change in visceral fat levels will be measured using InBody570 with scores ranging from 1-20, with the higher score indicating increased visceral fat (worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects nine weeks of intense exercise training will have on weight, inflammation, and intestinal bacteria composition of overweight and obese adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).\n2. Individuals who volunteer for the 54-day exercise program.\n3. Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.\n4. Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.\n5. Individuals who are not taking probiotics.\n6. Individuals who are not taking Metformin.\n7. Individuals who are cleared by their physician to perform strenuous exercise.\n8. Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.\n9. Individuals who are between 18 and 60.\n\nExclusion criteria:\n\n1\\. Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.'}, 'identificationModule': {'nctId': 'NCT04138303', 'briefTitle': 'Exercise and Nutrition on Obese Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'The Effects of a Calorie-Restrictive Low-Carbohydrate Diet Versus an Unrestrictive Ancestral Diet on Microbiota and Cardiometabolic Disease Markers of Obese Individuals Performing an Intense Exercise Program', 'orgStudyIdInfo': {'id': '20190936'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Only Group (EX)', 'description': 'Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.', 'interventionNames': ['Other: Exercise Protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise with CR-LC Group', 'description': 'Participants will receive the exercise protocol and CR-LC Diet regimen.', 'interventionNames': ['Other: Exercise Protocol', 'Other: Calorie-Restrictive Low Carbohydrate Diet (CR-LC)']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise with Ancestral Diet (AD) Group', 'description': 'Participants will receive the exercise protocol and AD regimen.', 'interventionNames': ['Other: Exercise Protocol', 'Other: Ancestral Diet (AD)']}], 'interventions': [{'name': 'Exercise Protocol', 'type': 'OTHER', 'description': 'The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise. Exercises are performed in person as a group with other participating subjects and lead by certified instructors. Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.', 'armGroupLabels': ['Exercise Only Group (EX)', 'Exercise with Ancestral Diet (AD) Group', 'Exercise with CR-LC Group']}, {'name': 'Calorie-Restrictive Low Carbohydrate Diet (CR-LC)', 'type': 'OTHER', 'description': 'Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. CR-LC consists of caloric and macronutrient restrictions. Caloric restrictions involves a 40% deficit from calculated total daily energy expenditure. Macronutrient restriction involves a high protein, low carbohydrate diet (35% protein, 25% carbohydrate and 40% fat).', 'armGroupLabels': ['Exercise with CR-LC Group']}, {'name': 'Ancestral Diet (AD)', 'type': 'OTHER', 'description': 'Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. AD consists of consuming only whole foods and avoiding processed foods. Emphasis will be on food quality with no caloric or macronutrient restrictions.', 'armGroupLabels': ['Exercise with Ancestral Diet (AD) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33146', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Wesley Smith, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Wesley Smith', 'investigatorAffiliation': 'University of Miami'}}}}