Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-29 @ 4:49 AM
Study NCT ID:
NCT06550466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-30', 'size': 627442, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-06T17:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In this three-arm randomised crossover study, sixteen young adult men (age: 28 ± 4) will be recruited in good physical condition. Participants will be exercised following a 12-hour overnight fast (FAST) and exercised 90 minutes after a meal (FED) to test the temporal sensitivity of the loaded bone to absorbed nutrients. Participants will also attend a breakfast-only arm (without the exercise protocol).\n\nParticipants will undergo a baseline assessment for health history (PAR-Q). The blood samples will be collected (10ml) and osteogenic response to exercise will be determined by measuring markers of bone formation; P1NP and resorption; CTX-1 and cortisol; marker of physiological and psychological stress. Insulin and glucose measurements will allow to assess the change of concentrations in fasted and fed states.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-terminal telopeptide of type-1 collagen (CTX-1)', 'timeFrame': 'Between pre-exercise and 2 hours following the exercise timepoints', 'description': 'The primary endpoint of this study is the change of the bone resorption biomarker C-terminal telopeptide of type-1 collagen (CTX-1) expression'}], 'secondaryOutcomes': [{'measure': 'Procollagen type 1 N-terminal propeptide (P1NP)', 'timeFrame': 'Between pre-exercise and 2 hours following the exercise timepoints', 'description': 'The change of the bone formation biomarker procollagen type 1 N-terminal propeptide (P1NP) expression'}, {'measure': 'Cortisol', 'timeFrame': 'Between pre-exercise and 2 hours following the exercise timepoints', 'description': 'Markerof physiological and psychological stress is assessed and because of its promotion of bone resorption'}, {'measure': 'Insulin', 'timeFrame': 'Between pre-exercise and 2 hours following the exercise timepoints', 'description': 'The change of concentration in fasted and fed states is assessed'}, {'measure': 'Glucose', 'timeFrame': 'Between pre-exercise and 2 hours following the exercise timepoints', 'description': 'The change of concentration in fasted and fed states is assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteopenia or Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Osteoporosis is a major contributor to loss of independence due to bone fractures and resulting hospital treatments lead to significant morbidity. While pharmacological treatments can reduce consequences of osteoporosis, there is a pressing need for non-pharmacological interventions to improve bone health across the life-course and to reduce likelihood of age-related bone disease.\n\nThis study will allow us to determine whether synergistic potentiating effects on bone metabolism are observed in humans in relation to the timing of food ingestion and what recommendations can be made to people with respect to food ingestion and exercise to obtain the maximal bone benefits from aerobic exercise. Furthermore, if we can identify interventions that potentiate bone\'s response to aerobic exercise in younger adults, then such interventions may have the ability to maximise bone mass in younger adults so that with ageing, the additional bone mineral density and improved bone microarchitecture would extend the time before osteoporotic "fracture thresholds" are reached. Therefore, understanding the bone metabolic response to exercise following fasting and feeding in younger adults is important.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male (females excluded to remove the interplay between menstrual cycle and bone turnover)\n* Caucasian ethnicity\n* Aged 28 ± 4 years\n* Are physically active (meet the UK guidelines for physical activity of at least 150 minutes moderate intensity activity and/or at least 75 minutes of vigorous intensity activity per week)\n* Otherwise, healthy, able and willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Current smokers\n* Excessive alcohol consumption (max 15 alcohol units/week)\n* Any musculoskeletal injury/disabilities\n* Any conditions known to affect bone metabolism (e.g. uncontrolled hyper-/hypothyroidism, hyperparathyroidism, hypo-/hypercalcaemia) or malabsorption syndromes (e.g. Crohn's disease, coeliac disease or inflammatory bowel disease).\n* Taking any medication known to affect bone metabolism (such as glucocorticoids or bisphosphonates)\n* Positive Covid-19 test within the last 8 weeks\n* Suffered a fracture in the previous 12 months\n* Sedentary status (see physical activity inclusion criteria above)\n* Have been told by medical professionals that they should not take part in moderate to high intensity exercise\n* Should not be a professional athlete or take part in significant competitive recreational activity (takes no more than 4 structured exercise sessions per week on average)\n* History of diagnosed eating disorders"}, 'identificationModule': {'nctId': 'NCT06550466', 'briefTitle': 'The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Hallam University'}, 'officialTitle': 'The Influence of Pre-exercise Feeding on Acute Bone Turnover Biomarkers in Response to Physical Activity in Healthy Participants', 'orgStudyIdInfo': {'id': 'ER52048815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breakfast only', 'description': 'Breakfast only without the exercise protocol', 'interventionNames': ['Other: Breakfast only']}, {'type': 'EXPERIMENTAL', 'label': 'FAST', 'description': 'Participants will be exercised 90 minutes following a 12-hour overnight fast', 'interventionNames': ['Other: FAST']}, {'type': 'EXPERIMENTAL', 'label': 'FED', 'description': 'Participants will be exercised 90 minutes after a meal', 'interventionNames': ['Other: FED']}], 'interventions': [{'name': 'Breakfast only', 'type': 'OTHER', 'description': 'Participants will attend a breakfast-only arm without the exercise protocol.', 'armGroupLabels': ['Breakfast only']}, {'name': 'FAST', 'type': 'OTHER', 'description': 'Participants will be exercised for 90 minutes following a 12-hour overnight fast', 'armGroupLabels': ['FAST']}, {'name': 'FED', 'type': 'OTHER', 'description': 'Participants will be exercised 90 minutes after a breakfast', 'armGroupLabels': ['FED']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Simon Bowles, PhD', 'role': 'CONTACT', 'email': 's.bowles@shu.ac.uk', 'phone': '00441142254216'}, {'name': 'Jasmine Samvelyan, PhD', 'role': 'CONTACT', 'email': 'jasmine.samvelyan@aru.ac.uk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Hallam University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anglia Ruskin University', 'class': 'OTHER'}, {'name': 'University of Sheffield', 'class': 'OTHER'}, {'name': 'Manchester Metropolitan University', 'class': 'OTHER'}, {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}