Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT05897567
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ketogenic Diet on Muscle Hypertrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D055423', 'term': 'Diet, Ketogenic'}, {'id': 'D066273', 'term': 'Diet, Western'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mammalian target of rapamycin (mTOR) signalling', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Measurement of the change in muscle protein anabolic signalling pathway in response to a single bout of resistance exercise by western blot analysis.'}], 'secondaryOutcomes': [{'measure': 'Skeletal muscle mass', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Measurement of the change in kilograms of muscle mass via Dexa'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Nutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of 4 weeks of carbohydrate deprivation (through a ketogenic diet) on hypertrophy signalling after a single bout of exercise in healthy trained male subjects, and the impact on body composition, muscle strength, and blood parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 2 years of resistance-training experience\n* Body mass index: more than 18 kg/m2 and less than 30 kg/m2\n\nExclusion Criteria:\n\n* metabolic diseases or noncommunicable diseases (cardiovascular, liver, respiratory, cancer, etc)\n* experience with the ketogenic diet (last six months)\n* acute inflammatory status\n* treatment with steroids in the past 3 months'}, 'identificationModule': {'nctId': 'NCT05897567', 'briefTitle': 'Effect of Ketogenic Diet on Muscle Hypertrophy', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Effects of Ketogenic Diet on Muscle Hypertrophic Response to Resistance Exercise', 'orgStudyIdInfo': {'id': 'KETO-EX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ketogenic diet', 'description': 'Participants will perform a single exercise bout after 4 weeks of resistance training combined with a ketogenic diet (KD group).', 'interventionNames': ['Other: resistance training', 'Other: ketogenic diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'western diet', 'description': 'Participants will perform a single exercise bout after 4 weeks of resistance training combined with a western diet (WD group).', 'interventionNames': ['Other: resistance training', 'Other: western diet']}], 'interventions': [{'name': 'resistance training', 'type': 'OTHER', 'description': 'All participants perform a four-day resistance training aimed to stimulate a hypertrophic response.', 'armGroupLabels': ['ketogenic diet', 'western diet']}, {'name': 'ketogenic diet', 'type': 'OTHER', 'description': 'Subjects allocated to the ketogenic diet arm (KD group) consume less than 50 g of carbohydrates per day.', 'armGroupLabels': ['ketogenic diet']}, {'name': 'western diet', 'type': 'OTHER', 'description': 'Subjects allocated to the western diet arm (WD group) consume a standard diet based on 55% of their daily calories from carbohydrates.', 'armGroupLabels': ['western diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35131', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Paoli, MD', 'role': 'CONTACT', 'email': 'antonio.paoli@unipd.it', 'phone': '+390498275318'}], 'facility': 'Nutex LAB', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Giuseppe Cerullo', 'role': 'CONTACT', 'email': 'giuseppe.cerullo@unipd.it', 'phone': '+00393200218377'}], 'overallOfficials': [{'name': 'Antonio Paoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Padova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}