Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 7:29 PM
Study NCT ID:
NCT05356559
Status:
UNKNOWN
Last Update Posted:
2022-05-02
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fish Protein Supplementation and Sarcopenia Outcomes in the Community
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel randomised control trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lipid profile', 'timeFrame': 'Change over 8 weeks', 'description': 'Measured by Clinical Chemistry analyzer'}, {'measure': 'Vitamin D status', 'timeFrame': 'Change over 8 weeks', 'description': 'Measured by LC-MS'}, {'measure': 'Inflammation', 'timeFrame': 'Change over 8 weeks', 'description': 'Cytokine profile measured by ELISA'}, {'measure': 'Kidney function', 'timeFrame': 'Change over 8 weeks', 'description': 'Measured by Clinical Chemistry analyzer'}, {'measure': 'Liver function', 'timeFrame': 'Change over 8 weeks', 'description': 'Measured by Clinical Chemistry analyzer'}], 'primaryOutcomes': [{'measure': 'Lean weight', 'timeFrame': 'Change over 8 weeks', 'description': 'Measured by Bio-Electrical Impedance Analysis'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'Change over 8 weeks', 'description': 'Measured via hand grip dynamometry'}, {'measure': 'Mobility', 'timeFrame': 'Change over 8 weeks', 'description': 'Assessed through 3 meter Timed up and go Test (time to walk 3 metre)'}, {'measure': 'Exercise tolerance', 'timeFrame': 'Change over 8 weeks', 'description': 'Six minute walk test - distance travelled over 6 minutes'}, {'measure': 'Blood pressure', 'timeFrame': 'Change over 8 weeks', 'description': 'Measured by a brachial blood pressure monitor'}, {'measure': 'Walking speed', 'timeFrame': 'Change over 8 weeks', 'description': 'Assessed by the gait speed test in a 4-meter distance'}, {'measure': 'Functional fitness', 'timeFrame': 'Change over 8 weeks', 'description': 'Assessed by time taken to perform five rises with arms crossed resting hands on their shoulders from seated.'}, {'measure': 'Lean weight', 'timeFrame': 'Change over 8 weeks', 'description': 'Measured by DXA scanner (grams) (Ulster site only)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'Fish protein', 'Fish hydrolysates', 'Protein supplementation', 'Older adults', 'Community', 'Muscle strength'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': "Sarcopenia is a progressive and generalised skeletal muscle disorder involving the accelerated loss of muscle mass and function that is associated with increase adverse outcomes including falls, functional decline, frailty and mortality. Diet, specifically protein has been proposed to have a role in the prevention and treatment of muscle loss in the older adult population nevertheless there is paucity of research on the effect of protein supplementation on lean body mass and other clinical outcomes in older adults.\n\nThis 2-arm parallel, double-blind, randomised, controlled dietary supplement human intervention study aims to investigate the effect of consuming 12.5g (twice daily) Blue Whiting Protein Hydrolysates daily in combination with exercise for 8 weeks on whole body lean mass tissue and measures of muscle strength and functionality in free living community dwelling older adults.\n\nParticipants (N150; 75/site (Ulster \\& Limerick); 75/group; 50-70 years) will be stratified by age, gender and BMI and randomly allocated to consume two sachets of either the Blue Whiting Protein Hydrolysates powder daily (12.5g at breakfast and lunch (Total 25g)), (mixed with an everyday food / drink product (provided by Ulster University) or an isocalorific maltodextrin citrus flavoured powder (Control) (mixed with an everyday food / drink product).\n\nAssessments to be undertaken pre and post intervention include; body composition including lean tissue mass measured by DXA whole body scan (Ulster site only), Bio-Electrical Impedance Analysis (BIA), hand grip strength, a 'timed get up and go' test, 6 minute walk test, gait speed test, chair stand test, blood pressure measurements, a quality of life questionnaire, a health and lifestyle questionnaire and a physical activity questionnaire. A trained phlebotomist will obtain a 40ml max blood sample from each participant pre and post intervention. Blood samples will be used to measure markers associated with sarcopenia (serum 25(OH)D, pro inflammatory cytokine profile, full lipid profiles and kidney and liver profiles). A 4-day food diary will be collected at baseline only to determine habitual protein intake. At post intervention only, bone mineral density at the spine and hip will be measured by a DXA scanner.\n\nComparisons will be made (ANCOVA) between the intervention group and control group over time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free-living, apparently healthy older adults\n* Able to fast from 10pm prior to the appointment\n* Aged 50-70 years at recruitment\n* Not regularly taking protein supplements\n* Free from serious musculoskeletal injury\n\nExclusion Criteria:\n\n* Adults \\<50 years at recruitment\n* Food allergy or intolerance that would prevent consumption of fish\n* Diagnosed with any form of terminal disease or past medical history of conditions or medications that may interfere with supplementation and/or study outcomes, such as diabetes, kidney, digestive, thyroidal disease\n* Cognitive impairment\n* Exclusively receiving enteral or parenteral nutrition\n* Currently taking any protein supplement\n* Undertaking resistance exercise regularly\n* Planning to lose weight/go on a special diet\n* Any conditions/anomalies that could potentially interfere with the DXA\n* Been advised not to undertake physical activity'}, 'identificationModule': {'nctId': 'NCT05356559', 'acronym': 'SARCO_COMM', 'briefTitle': 'Fish Protein Supplementation and Sarcopenia Outcomes in the Community', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulster'}, 'officialTitle': 'Blue Whiting Protein Hydrolysates and Sarcopenia Outcomes in Free-living, Community Dwelling Older Adults (SARCO_COMM).', 'orgStudyIdInfo': {'id': '21/EM/0140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fish protein', 'interventionNames': ['Dietary Supplement: Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Intervention', 'type': 'DIETARY_SUPPLEMENT', 'description': '12.5g (twice daily) Blue Whiting Protein Hydrolysates daily for 8 weeks', 'armGroupLabels': ['Fish protein']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Isocalorific Maltodextrin Citrus Flavoured Powder for 8 weeks', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT52 1SA / V94 T9PX', 'city': 'Coleraine / Limerick', 'state': 'Co.Londonderry / Ireland', 'country': 'United Kingdom', 'contacts': [{'name': 'Ruth K Price', 'role': 'CONTACT', 'email': 'rk.price@ulster.ac.uk', 'phone': '+442870123878'}, {'name': 'Julie J Sittlington', 'role': 'CONTACT', 'email': 'jj.sittlington@ulster.ac.uk', 'phone': '+442870124101'}, {'name': 'Richard Fitzgerald', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Human Intervention Studies Unit, Ulster University / Physical Education and Sport Sciences,'}], 'centralContacts': [{'name': 'Philip J Allsopp', 'role': 'CONTACT', 'email': 'pj.allsopp@ulster.ac.uk', 'phone': '+44 28 7012 3125'}, {'name': 'Mary M Slevin', 'role': 'CONTACT', 'email': 'mm.slevin@ulster.ac.uk', 'phone': '+44 08 7012 3041'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulster', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Limerick', 'class': 'OTHER'}, {'name': 'Bio-Marine Ingredients Ireland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}