Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT05533502
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2022-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Plant-Based Protein and Marine-Based Multi-Mineral Supplement and Bone Remodeling in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Single Blind Study (Investigator only)'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A block-randomized, within-subject, two-day, crossover design examining acute (0-4 h) postprandial changes in different gut hormone concentrations and bone remodeling biomarkers in 12 healthy, young adults following ingestion of a combination plant-based protein and marine-based multi-mineral supplement or control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2022-09-05', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone turnover', 'timeFrame': 'Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)', 'description': 'A balance of the difference between the magnitude and time course of the acute change (0-4 hours) in plasma C-terminal telopeptide of type 1 collagen (CTX) in ng/mL, a measure of bone resorption, and procollagen type 1 amino-terminal propeptide (P1NP) in ng/ml, a measure of bone formation.'}], 'secondaryOutcomes': [{'measure': 'Change in regulator of bone metabolism - Parathyroid hormone', 'timeFrame': 'Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)', 'description': 'The magnitude and time course of the acute change (0-4 hours) in plasma parathyroid hormone (PTH) measured in pmol/L.'}, {'measure': 'Change in ionized calcium and potassium.', 'timeFrame': 'Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Whole Blood)', 'description': 'The magnitude and time course of the acute change (0-4 hours) in ionized calcium and potassium.'}, {'measure': 'Vitamin D Status', 'timeFrame': 'Pre-ingestion (Plasma)', 'description': 'Pre-ingestion total plasma 25 (OH)D level'}, {'measure': 'Change in insulin and glucose', 'timeFrame': 'Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)', 'description': 'The magnitude and time course of the acute change (0-4 hours) in plasma insulin and glucose'}, {'measure': 'Change in incretin peptides', 'timeFrame': 'Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)', 'description': 'The magnitude and time course of the acute change (0-4 hours) in enterogastric peptide glucose-dependent insulinotropic peptide (GIP1-42) measured in pg/mL, glucagon-like peptide-1 (GLP-17-36) measured in pg/mL and GLP-2 (1-33) measured in pg/mL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrition', 'plant', 'marine', 'protein', 'bone', 'skeletal', 'health', 'dietary supplements', 'sustainable'], 'conditions': ['Bone Resorption', 'Bone and Bones']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://aquamin.com/products/marine-minerals-aquamin-f/', 'label': 'Related Info'}, {'url': 'https://aturaproteins.com/plant-proteins/fava-bean-protein/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Nutrient intake of calcium and protein are known to function as regulators of bone remodeling. Specifically, a balanced rate of bone resorption and bone formation (i.e. bone remodeling process) is required to maintain bone health. However, a high remodeling rate, or an imbalance between formation and resorption, as well as suboptimal nutrient intake are known to contribute to fracture risk and bone dysfunction.\n\nGut-derived hormones represent an important link between nutrient intake and bone remodeling (i.e. gut-bone axis). A sustainable nutritional intervention that positively modulates the postprandial responses of gut-derived hormones and the linked bone remodeling processes is an attractive option for the optimization of bone health in young adults.\n\nThe proposed nutrient intervention seeks to explore the bioefficacy of a combination plant-based protein and marine-based multi-mineral supplement following oral ingestion in young, healthy men and women. A postprandial time-course study will be undertaken to examine the acute effects and/or associations between different gut-derived hormones and biomarkers of bone metabolism.', 'detailedDescription': 'A block-randomized, within-subject, two-day, crossover design examining acute (0-4 hour) postprandial changes in different gut-derived hormone concentrations and biomarkers of bone metabolism in 12 healthy, young adults following ingestion of a combination plant-based protein and marine-based multi-mineral supplement or control.\n\nEach participant will consume (in a random manner) either one of two investigational products (i.e., combined nutritional supplement or control). The combined nutritional supplement will consist of: 0.3 g/kg body mass of ATURA Fava-Bean Protein and 800mg of Aquamin F (a highly bioactive source of minerals rich in calcium) dissolved in 500ml water volume. The control product will consist of 500ml water volume without the protein and multi-mineral nutritional composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 to 35 years.\n* Recreationally active (150-300 min/week of moderate physical activity).\n* Healthy (i.e.,not presenting with injury, illness, medication, history of chronic disease, or known allergies/intolerance (e.g. favism) to the ingredients contained in either formulation.'}, 'identificationModule': {'nctId': 'NCT05533502', 'briefTitle': 'Combination Plant-Based Protein and Marine-Based Multi-Mineral Supplement and Bone Remodeling in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Limerick'}, 'officialTitle': 'Acute Effects of a Combination Plant-Based Protein and Marine-Based Multi-Mineral Supplement on Postprandial Gut Hormones and Bone Remodeling in Young Adults', 'orgStudyIdInfo': {'id': '2022_03_06_EHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement', 'description': 'Fava-Bean Protein Concentrate and Aquamin F', 'interventionNames': ['Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'Placebo Control', 'interventionNames': ['Dietary Supplement: Placebo Control']}], 'interventions': [{'name': 'Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of the Test Product at 07.00am - Fava-bean protein concentrate dosed at 0.33 g/kg body mass and Aquamin F dosed at 800mg in 500 ml water volume. Supplied by Marigot Limited, Strand Farm Currabinny, Co. Cork, Ireland', 'armGroupLabels': ['Dietary Supplement: Combined Plant-Based Protein and Marine-Based Multi-Mineral Supplement']}, {'name': 'Placebo Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of the Control Product at 07.00am - 500ml water volume.', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V94 T9PX', 'city': 'Limerick', 'country': 'Ireland', 'facility': 'Faculty of Education & Health Sciences, University of Limerick,', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}], 'overallOfficials': [{'name': 'Philip M Jakeman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Limerick'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Limerick', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marigot Ltd.', 'class': 'INDUSTRY'}, {'name': 'Enterprise Ireland', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}