Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-08 @ 4:48 AM
Study NCT ID:
NCT07283406
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-15
First Post:
2025-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High-intensity Interval Training on Cardiometabolic Health and Physical Fitness in Young Adults With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum oxygen uptake (VO₂max)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'VO₂max (ml/min/kg): Change from Baseline at 12 weeks, measured using a submaximal exercise test based on the Åstrand-Ryhming protocol'}, {'measure': 'Weight', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Weight (kg): Changes in weight from baseline to 12 weeks of intervention.'}, {'measure': 'Height', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Height (cm): Changes in height from baseline to 12 weeks of intervention.'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'BMI (kg/m2): Change from Baseline at 12 weeks, calculated by: weight (kg)/ height (m\\^2)'}, {'measure': 'Body fat percentage', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Body fat percentage (%): Changes in body fat assessed by bioelectrical impedance analysis (BIA)'}, {'measure': 'Muscle mass percentage', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Muscle mass percentage (%): Changes in muscle mass measured using bioelectrical impedance analysis (BIA)'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Waist circumference (cm): Changes in waist circumference will be measured using a Lufkin measuring tape (USA) following the guidelines of the International Society for the Advancement of Kinanthropometry (ISAK)'}, {'measure': 'Waist-to-hip ratio', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Waist-to-hip ratio: Changes in waist-to-hip ratio will be calculated by dividing the waist measurement by the hip measurement'}, {'measure': 'Glucose', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Glucose (mg/dl): Changes from baseline to 12 weeks of intervention'}, {'measure': 'Triglycerides', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Triglycerides (mg/dl): Changes from baseline to 12 weeks of intervention'}, {'measure': 'Total cholesterol', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Total cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention'}, {'measure': 'HDL cholesterol', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'HDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention'}, {'measure': 'LDL cholesterol', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'LDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'CRP (mg/dl): Changes from baseline to 12 weeks of intervention'}, {'measure': 'Systolic blood pressure (SBP)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'SBP (mmHg): Changes from baseline to 12 weeks of intervention'}, {'measure': 'Diastolic blood pressure (DBP)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'DBP (mmHg): Changes from baseline to 12 weeks of intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'HIIT', 'MICT'], 'conditions': ['Obesity & Overweight']}, 'descriptionModule': {'briefSummary': 'The objective of the present project is to compare the effects of two types of training on cardiovascular health components and physical fitness in young adults with obesity.', 'detailedDescription': 'Obesity represents a serious public health problem, and its prevalence continues to rise worldwide. Numerous studies have documented the positive effects of moderate-intensity continuous training (MICT) on cardiovascular and metabolic health in individuals living with obesity; however, the effects of high-intensity interval training (HIIT) are still being explored.\n\nTherefore, the objective of the present research protocol is to analyze and compare the effects of an MICT program and an HIIT program on cardiometabolic biomarkers and physical fitness in young adults with obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young adults\n* BMI ≥ 30 kg/m\\^2" and \\< 40 kg/m\\^2\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Participants who smoke\n* Clinical diagnosis of hypothyroidism\n* Clinical diagnosis of type 1 diabetes mellitus\n* Clinical diagnosis of type 2 diabetes mellitus\n* Clinical diagnosis of grade 3 obesity\n* Clinical diagnosis of hypertension\n* Clinical diagnosis of acute myocardial infarction or angina pectoris\n* Use of nitrates and calcium channel blockers within 4 days prior to the start of the study\n* Use of beta-blockers or hypoglycemic agents within 7 days prior to the intervention\n* Pregnant women\n* Breastfeeding women\n* Men consuming more than 40 g of alcohol per day or women consuming more than 20 g per day\n* Postural and biomechanical disorders (knee, foot, and spine)'}, 'identificationModule': {'nctId': 'NCT07283406', 'briefTitle': 'Effect of High-intensity Interval Training on Cardiometabolic Health and Physical Fitness in Young Adults With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario de Tlajomulco, Universidad de Guadalajara'}, 'officialTitle': 'Effect of High-intensity Interval Training on Cardiometabolic Health and Physical Fitness in Young Adults With Obesity', 'orgStudyIdInfo': {'id': 'CUTLAJO251028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIIT Group', 'description': 'This group will train for 12 weeks', 'interventionNames': ['Other: High-intensity interval training intervention', 'Other: Educational sessions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MICT Group', 'description': 'This group will train for 12 weeks', 'interventionNames': ['Other: Moderate-intensity continuous training intervention', 'Other: Educational sessions']}], 'interventions': [{'name': 'High-intensity interval training intervention', 'type': 'OTHER', 'description': 'The HIIT group will undergo training for 12 weeks, with a frequency of three sessions per week, completing a total of 36 sessions. Each session will include a 5-minute warm-up and a 5-minute cool-down at 50-60% of maximum heart rate (HRmax). The training protocol will consist of 2-minute high-intensity intervals performed at 90-95% HRmax, corresponding to a Borg rating of perceived exertion (RPE) of 17-18, alternated with 2-minute recovery periods at 70% HRmax (RPE 12-14). A total of five intervals will be completed per session, resulting in an overall high-intensity workload of 18 minutes. All training sessions will be conducted on a stationary cycle ergometer', 'armGroupLabels': ['HIIT Group']}, {'name': 'Moderate-intensity continuous training intervention', 'type': 'OTHER', 'description': 'The MICT group will perform moderate-intensity continuous training at 60-70% HRmax, corresponding to an RPE of 12-14, for 35-45 minutes on a stationary cycleergometer. Heart rate and physical activity levels will be continuously monitored in both groups using a chest-strap heart rate sensor (Polar H9, Polar Electro, Finland).', 'armGroupLabels': ['MICT Group']}, {'name': 'Educational sessions', 'type': 'OTHER', 'description': 'In addition, four educational sessions will be conducted to provide dietary recommendations to all participants. These sessions will aim to promote balanced eating habits and to discourage the excessive consumption of ultra-processed foods or alcohol, as these factors could interfere with the intervention outcomes.', 'armGroupLabels': ['HIIT Group', 'MICT Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45650', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Centro Universitario de Tlajomulco, Universidad de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario de Tlajomulco, Universidad de Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'José Manuel Pérez Casillas', 'investigatorAffiliation': 'Centro Universitario de Tlajomulco, Universidad de Guadalajara'}}}}