Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-30 @ 12:35 PM
Study NCT ID:
NCT04496856
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2020-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients
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': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Palatability of the protein supplementation', 'timeFrame': '30 days', 'description': 'Assessed on a scale from 1-5'}, {'measure': 'Consistency of the protein supplementation', 'timeFrame': '30 days', 'description': 'Assessed on a scale from 1-5'}, {'measure': 'Compliance of the protein supplementation intake', 'timeFrame': 'Weekly for 30 days', 'description': 'Assessed trough a weekly form, which the participants will fill in'}, {'measure': 'Rapported side effects', 'timeFrame': '30 days', 'description': 'Participants will be informed to rapport if they experience any side effects throughout the intervention'}], 'primaryOutcomes': [{'measure': 'The difference in fat free mass', 'timeFrame': 'Weekly for 30 days', 'description': 'The outcome will be monitored through BIA and the development of fat free mass in the operated leg will be compared to the development of fat free mass in the non-operated leg.'}], 'secondaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': 'Weekly for 30 days', 'description': 'The amount of days until the wound is healed (defined as: the epithelium is covered without crust). This will be monitored trough pictures and assessed on a scale from 1-5 by a masked doctor.'}, {'measure': 'Redness and infection', 'timeFrame': 'Weekly for 30 days', 'description': 'The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.'}, {'measure': 'Handgrip strength', 'timeFrame': 'Weekly for 30 days', 'description': 'Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage'}, {'measure': 'Extension strength of quadriceps femoris', 'timeFrame': 'Weekly for 30 days', 'description': 'Measured in amounts of repetitions of 0.5 or 1.0 kg.'}, {'measure': 'Life quality', 'timeFrame': 'Weekly for 30 days', 'description': 'Measured trough EuroQol-5D-5L'}, {'measure': 'Difference in functional ability (NMS)', 'timeFrame': 'Weekly 30 days', 'description': 'Assessed by New mobility score'}, {'measure': 'Difference in Chair stand test', 'timeFrame': 'Weekly for 30 days', 'description': 'Measured by amount of repetitions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Arthroplasty', 'Collagen', 'Whey protein', 'Knee Arthroplasty'], 'conditions': ['Hip Arthritis', 'Sarcopenia', 'Knee Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effect of whey protein and collagen on fat free mass, muscle strength, functional ability, wound healing and life quality in elderly patients undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65+ years\n* Scheduled elective knee- or hip surgery\n* Must be able to understand and speak danish\n* Must be able to chew and swallow food with a regular consistency\n* Must be able to consume the assigned protein supplementation\n* Must be able to consent participation\n\nExclusion Criteria:\n\n* Vegan\n* Demensia\n* Critical complications to the surgery which prevents the patient from participating in the rehabilitation program\n* Plasma-creatinin above 250 micromol/L\n* Palliative patients\n* Known intolerance of whey protein and/or collagen\n* Patients with a pacemaker'}, 'identificationModule': {'nctId': 'NCT04496856', 'briefTitle': 'Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'The Effects of Whey Protein and Collagen on Fat Free Mass, Muscle Strength and Wound Healing in Elderly Patients Undergoing Elective Knee- or Hip Surgery', 'orgStudyIdInfo': {'id': 'ValleKollagen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagen', 'description': 'Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days', 'interventionNames': ['Dietary Supplement: Whey protein and Collagen supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Whey Protein', 'description': 'Participants of this arm are going to consume 30 g of whey protein daily for 30 days', 'interventionNames': ['Dietary Supplement: Whey protein and Collagen supplementation']}], 'interventions': [{'name': 'Whey protein and Collagen supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants of each arm will consume 30 g daily of the assigned protein supplementation for 30 days. The protein supplementation will be given as protein powder which the participants will have to dissolve in cold drinks. During the intervention fat free mass, muscle strength, functional ability, wound healing and life quality of the participants will be monitored.', 'armGroupLabels': ['Collagen', 'Whey Protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Gentofte Municipality', 'state': 'Hellerup', 'country': 'Denmark', 'facility': 'Herlev/Gentofte Hospital', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}