Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT04676958
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2020-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
viTAmin K2 and rEcOVery From ExeRcise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D024482', 'term': 'Vitamin K 2'}], 'ancestors': [{'id': 'D014812', 'term': 'Vitamin K'}, {'id': 'D009285', 'term': 'Naphthoquinones'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010836', 'term': 'Phytol'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-18', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in lean mass', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in lean mass'}, {'measure': 'Change in blood glucose', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in blood glucose'}, {'measure': 'Change in blood lipids', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in blood lipids'}, {'measure': 'Change in plasma insulin', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in plasma insulin'}, {'measure': 'Change in fat mass', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in fat mass'}, {'measure': 'Change in muscle thickness', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Change in muscle thickness'}, {'measure': 'Change in exercise substrate utilisation', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Energy expenditure, carbodhydrate and fat oxidation during treadmill walking'}], 'primaryOutcomes': [{'measure': 'Change in post exercise recovery of muscle strength', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Muscle strength (MVC) of the knee extensor muscles will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise'}], 'secondaryOutcomes': [{'measure': 'Change in pain free range of motion during knee extension exercise', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'The range of motion which is pain free will be measured during knee extension using a goniometer before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise'}, {'measure': 'Change in post exercise recovery of functional abilities', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Time to complete 5 chair rises will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise'}, {'measure': 'Change in post exercise recovery of sEMG activity', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Quadriceps muscle sEMG will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise'}, {'measure': 'Change in post exercise interleukin-6', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Circulating interleukin-6 will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise'}, {'measure': 'Change in post exercise peroxiredoxin 3 redox state', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Circulating peroxiredoxin 3 redox state will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise'}, {'measure': 'Change in vitamin K levels', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Vitamin K will be measured in baseline and 12 week samples'}, {'measure': 'Change in Carboxylated Osteocalcin levels', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Carboxylated Osteocalcin will be measured in baseline and 12 week samples'}, {'measure': 'Change in uncarboxylated Osteocalcin levels', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'uncarboxylated Osteocalcin will be measured in baseline and 12 week samples'}, {'measure': 'Change in carboxylated matrix gla-protein levels', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'carboxylated matrix gla-protein will be measured in baseline and 12 week samples'}, {'measure': 'Change in dephosphorylated-uncarboxylated matrix gla-protein levels', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'dephosphorylated-uncarboxylated matrix gla-protein will be measured in baseline and 12 week samples'}, {'measure': 'Change in post exercise F2 isoprostanes', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Circulating F2 isoprostanes will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Oxidative Stress', 'Vitamin K', 'Exercise', 'Strength', 'Recovery']}, 'referencesModule': {'references': [{'pmid': '36539791', 'type': 'DERIVED', 'citation': 'Lithgow H, Johnston L, Ho FK, Celis-Morales C, Cobley J, Raastad T, Hunter AM, Lees JS, Mark PB, Quinn TJ, Gray SR. Protocol for a randomised controlled trial to investigate the effects of vitamin K2 on recovery from muscle-damaging resistance exercise in young and older adults-the TAKEOVER study. Trials. 2022 Dec 20;23(1):1026. doi: 10.1186/s13063-022-06937-y.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study, therefore, is to investigate the effects of vitamin K2 supplementation on the physiological responses to an acute bout of resistance exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is able and willing to sign the Informed Consent From\n* No plans to change lifestyle (activity and nutrition) during the study period\n* Older group (n=40): 65 years of age or older.\n* Younger group (n=40): Aged 18-40 years\n\nExclusion Criteria:\n\n* Not currently, or in the last year, participating in more than 1h per week of vigorous aerobic physical activity or any resistance exercise\n* BMI \\> 30 kg/m2\n* diabetes\n* severe cardiovascular disease\n* seizure disorders\n* liver disease\n* uncontrolled hypertension (\\>150/90mmHg at baseline measurement)\n* cancer or cancer that has been in remission \\<5 years\n* ambulatory impairments which would limit ability to perform assessments of muscle function\n* dementia\n* currently taking Vitamin K2 supplements\n* currently taking Vitamin K antagonists/anticoagulants (e.g. warfarin)\n* current smoking\n* history of drug abuse\n* taking medication known to affect muscle (e.g. steroids).'}, 'identificationModule': {'nctId': 'NCT04676958', 'acronym': 'TAKEOVER', 'briefTitle': 'viTAmin K2 and rEcOVery From ExeRcise', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Effects of Vitamin K2 on Recovery From Muscle Damaging Exercise in Young and Older Adults', 'orgStudyIdInfo': {'id': '200190189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '380 mg capsule/day micro-crystalline cellulose', 'interventionNames': ['Dietary Supplement: Micro-crystalline cellulose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin K2', 'description': '380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2', 'interventionNames': ['Dietary Supplement: Vitamin K2']}], 'interventions': [{'name': 'Vitamin K2', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin K2', 'armGroupLabels': ['Vitamin K2']}, {'name': 'Micro-crystalline cellulose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Micro-crystalline cellulose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 8TA', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'University of Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Stuart Robert Gray', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kappa Bioscience', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Stuart Gray', 'investigatorAffiliation': 'University of Glasgow'}}}}