Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT07300332
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Training and Vitamin D Metabolism
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 25-hydroxyvitamin D', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': '25-OH-VD will be quantitatively determined in serum'}, {'measure': 'Change in plasma Vitamin D binding protein', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'Vitamin D binding protein will be determined in plasma'}, {'measure': 'Change in calcium concentration', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'Calcium concentration will be determined in serum'}, {'measure': 'Change in albumin concentration', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'Albumin concentration will be determined in serum'}, {'measure': 'Change in aspartate aminotransferase (SGOT)', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'SGOT will be determined in serum on a Clinical Chemistry analyzer'}, {'measure': 'Change in alanine aminotransferase (SGPT)', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'SGPT will be determined in serum on a Clinical Chemistry analyzer'}, {'measure': 'Change in gamma-glutamyl transferase (γ-GT)', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'γ-GT will be determined in serum on a Clinical Chemistry analyzer'}], 'secondaryOutcomes': [{'measure': 'Change in reduced glutathione levels', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'Reduced glutathione levels will be determined in blood erythrocytes'}, {'measure': 'Change in oxidized glutathione', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'Oxidized glutathione levels will be determined in blood erythrocytes'}, {'measure': 'Change in dietary intake', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'Dietary intake habits will be assessed through dietary recalls'}, {'measure': 'Change in physical activity level', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'Physical activity will be assessed via accelerometry'}, {'measure': 'Change in body composition', 'timeFrame': 'At baseline, 6 weeks and 12 weeks', 'description': 'Body composistion will be assessed via bioelectrical impedance analysis (BIA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overweight', 'obesity', 'vitamin D', '25-hydroxyvitamin D', 'high-intensity interval training'], 'conditions': ['Obesity & Overweight', 'Vitamin D']}, 'descriptionModule': {'briefSummary': 'The prevalence of Vitamin D deficiency is significantly higher in adults with overweight/obesity compared to those with normal BMI. The "entrapment" of Vitamin D in adipose tissue due to impaired lipolytic stimulation and/or adipose tissue dysfunction has been proposed as the driving mechanism. Exercise training has been proposed as a promising strategy to increase mobilization of Vitamin D from adipose tissue, given its well described role in stimulating lipolysis. Indeed, a recent study revealed that participation in moderate-intensity cardiovascular type exercise over winter can mitigate the decline in 25-hydroxyvitamin D \\[25(OH)D\\] in adults with overweight/obesity, independent of weight loss. The aim of this study is to investigate the impact of hybrid-type high-intensity interval training over winter on vitamin D metabolism, in adults with overweight/obesity.', 'detailedDescription': 'Thirty adults with overweight/obesity (both males and females) who will meet the inclusion criteria will be randomly assigned to either an Exercise group (n=15) or a Control group (n=15). The Exercise group will participate in three hybrid-type high-intensity interval training sessions per week over a 12-week period, while receiving a balanced diet. The Control group will receive a balanced diet but will not participate in exercise training. Both groups will provide a resting blood sample and undergo assessment of their body composition (via bioelectrical impedance analysis), daily dietary intake (via dietary recalls) and physical activity level (via accelerometry) at baseline (prior to intervention), 6 weeks and 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI = 25-35 kg/m2\n* Absence of musculoskeletal injuries\n* Absence of chronic health-related complications\n* Non-smokers\n\nExclusion Criteria:\n\n* Consumption of Vitamin D supplements\n* Consumption of anti-inflammatory drugs, statins and/or steroids'}, 'identificationModule': {'nctId': 'NCT07300332', 'acronym': 'Hybri-D', 'briefTitle': 'Exercise Training and Vitamin D Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'The Impact of Hybrid-type High-intensity Interval Training on Vitamin D Metabolism in Adults With Overweight/Obesity', 'orgStudyIdInfo': {'id': 'UTH_2612_8.10.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Exercise group will participate in three hybrid-type high-intensity interval training sessions per week over a 12-week period, while receiving a balanced diet', 'interventionNames': ['Other: Exercise training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Control group will receive a balanced diet but will not participate in exercise training', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Exercise training', 'type': 'OTHER', 'description': 'Receive a balanced diet and participate in three hybrid-type high-intensity interval training sessions per week over a 12-week period', 'armGroupLabels': ['Exercise group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Receive a balanced diet but abstain from any type of exercise training', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Trikala', 'state': 'Karyes', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Athanasios Z Jamurtas, PhD', 'role': 'CONTACT', 'email': 'ajamurt@uth.gr', 'phone': '2431047054'}, {'name': 'Ioannis G Fatouros, PhD', 'role': 'CONTACT', 'email': 'ifatouros@uth.gr', 'phone': '2431047047'}, {'name': 'Eytychia Giouvri, BSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Physical Education and Sport Science, University of Thessaly', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}], 'centralContacts': [{'name': 'Dimitrios Draganidis, PhD', 'role': 'CONTACT', 'email': 'ddraganidis@uth.gr', 'phone': '+302431047078'}, {'name': 'Ioannis G Fatouros, PhD', 'role': 'CONTACT', 'email': 'ifatouros@uth.gr', 'phone': '2431047047'}], 'overallOfficials': [{'name': 'Dimitrios Draganidis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Thessaly'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dimitrios Draganidis', 'investigatorAffiliation': 'University of Thessaly'}}}}