Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT06054620
Status:
UNKNOWN
Last Update Posted:
2023-11-13
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003094', 'term': 'Collagen'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Double blinded (investigators and participants). A lab member external to the investigation will code items for the intervention.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover to receive Collagen and Vitamin C (CVC) or Carbohydrate placebo. Unilateral leg exercise (EX) to give 4 outcomes. (1) CVC-EX; (2) CVC-REST; (3) PLACEBO-EX; (4) PLACEBO-REST'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intensity of Muscle Soreness', 'timeFrame': '24 hours', 'description': 'Subjective muscle soreness will be quantified using a visual analog scale on trial day mornings and evenings as well as before and after exercise. Using a line spanning 0 to 100 (100 being greatest soreness), participants will select a spot on the line indicating their subjective muscle soreness.'}], 'primaryOutcomes': [{'measure': 'Enrichment of Muscle Collagen', 'timeFrame': '9 hours', 'description': 'Overnight incorporation of orally ingested amino acid tracer (D5 Gly and D5 Phe) into mature collagen protein isolated from skeletal muscle biopsy samples taken 9 hours after consumption of the tracer-containing supplement (CVC or PLA) and rest or resistance exercise. Enrichment will be quantified via tandem LC-MS/MS.'}], 'secondaryOutcomes': [{'measure': 'Area of muscle with localized collagen remodelling', 'timeFrame': '9 hours', 'description': 'Immunofluorescence determined localization of collagen breakdown and synthesis using collagen hybridizing peptide and procollagen antibodies, respectively, on human skeletal muscle cross-sections.'}, {'measure': 'Concentration of Urinary Growth Hormone', 'timeFrame': '8 hours', 'description': 'Urine will be collected overnight to measure growth hormone secretion using chemiluminescence.'}, {'measure': 'Enrichment of Myofibrillar Protein', 'timeFrame': '9 hours', 'description': 'Overnight incorporation of orally ingested amino acid tracer (D5 Gly and D5 Phe) into myofibrillar proteins isolated from skeletal muscle biopsy samples taken 9 hours after consumption of the tracer-containing supplement (CVC or PLA) and rest or resistance exercise. Enrichment will be quantified via tandem LC-MS/MS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Collagen', 'Vitamin C', 'Carbohydrate placebo'], 'conditions': ['Interventional']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study will be to determine the influence of a presleep vitamin C-enriched, collagen-modelled supplement (CVC) on the metabolic fate of dietary glycine using a \\[2H5\\]glycine tracer within the intramuscular connective tissue at rest and after a bout of resistance exercise. Other outcomes will be related to regulation collagen remodelling in skeletal muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, recreationally active, male and female participants.\n* Healthy will be defined as someone who does not have a health condition that would compromise their ability to safely participate in the strenuous physical activity involved in our study as screened for by the Get Active Questionnaire.\n* Willing to abstain from resistance exercise for 2 weeks prior to the first metabolic trial and for the duration of the study.\n* Participants must be able to abstain from lower-body resistance and/or plyometric exercise for at least 2 weeks prior to the first metabolic trial.\n* Participants will be aged 18-35 years old.\n* Participants must be normal to overweight (e.g., BMI 18.5-30).\n* Participants are willing to abide by the compliance rules of this study (e.g., abstain from physical activity and alcohol 48h prior to each trial).\n* Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).\n\nExclusion Criteria:\n\n* Inability to adhere to any of the compliance rules judged by principal investigator or medical doctor.\n* Self-reported regular tobacco use.\n* Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.).\n* Regular use of anti-inflammatory drugs (e.g., ibuprofen).\n* Self-reported regularly sleeping less than an average of 7 hours over 3 days (minimum recommended daily amount).\n* Individuals who have participated in studies within the past year involving any of the stable isotopes in the study.\n* Use of birth control and discontinued use in the last 3-months (female only).'}, 'identificationModule': {'nctId': 'NCT06054620', 'briefTitle': 'The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling', 'orgStudyIdInfo': {'id': 'CVC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Collagen and Vitamin C', 'interventionNames': ['Dietary Supplement: Collagen and Vitamin C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Carbohydrate Placebo', 'interventionNames': ['Dietary Supplement: Carbohydrate Placebo']}], 'interventions': [{'name': 'Collagen and Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CVC'], 'description': 'Collagen-modelled crystalline amino acids (30g total, 8g glycine) and vitamin C (500 mg).', 'armGroupLabels': ['Collagen and Vitamin C']}, {'name': 'Carbohydrate Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Iso-caloric Placebo (30g maltodextrin).', 'armGroupLabels': ['Carbohydrate Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 2C9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dan R Moore, PhD', 'role': 'CONTACT', 'email': 'dr.moore@mail.utoronto.ca', 'phone': '647-946-4088'}, {'name': 'Paul L Babits, BKin', 'role': 'CONTACT', 'email': 'paul.babits@mail.utoronto.ca'}], 'facility': 'Goldring Centre for High Performance Sport at the University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Daniel R Moore, PhD', 'role': 'CONTACT', 'email': 'dr.moore@mail.utoronto', 'phone': '416-946-4088'}, {'name': 'Paul L Babits, BKin', 'role': 'CONTACT', 'email': 'paul.babits@mail.utoronto.ca', 'phone': '647-609-4710'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniel Moore', 'investigatorAffiliation': 'University of Toronto'}}}}