Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT06130956
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2023-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a 2-week Preoperative Vegan Diet Versus Omnivorous Diet on the Protein Turnover in the Osteoarthritic Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067269', 'term': 'Diet, Vegan'}], 'ancestors': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tissue-specific protein synthesis rates', 'timeFrame': 'During the 2-week preoperative period', 'description': 'Tissue-specific protein synthesis rates in the knee using D2O dosing methodology'}], 'secondaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'Measured at baseline and 1 day before surgery', 'description': 'Blood pressure measurement using an CE-certified ambulatory blood pressure monitor'}, {'measure': 'Change in plasma amino acids', 'timeFrame': 'During the 2-week preoperative period', 'description': 'Difference in circulating concentrations between the two diets. In addition, it will be investigated if plasma amino acids can be used as a marker for dietary intake.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteo Arthritis Knee', 'Protein Synthesis']}, 'descriptionModule': {'briefSummary': "Rationale: Protein from plant-based foods may be unable to stimulate protein synthesis due to a suboptimal essential amino acid content and a lower digestibility. However, a more optimal amino acid profile may be achieved by increasing portions sizes and blending multiple plant-based sources. Studies investigating the anabolic properties of vegan diets (total elimination of animal-based foods) rather than single plant-based foods in older adults are scarce. It remains unknown if a vegan diet can also affect protein synthesis rates in other musculoskeletal tissues than muscle.\n\nPrimary objective: To assess the effects of a 2-week preoperative vegan diet in comparison to an omnivorous diet on protein synthesis rates in Hoffa's fat pad, synovium, tendon, bone, ligaments, menisci, and cartilage in older adults with knee osteoarthritis undergoing total knee arthroplasty.\n\nSecondary objective: To assess the effects of a 2-week preoperative vegan diet in comparison to an omnivorous diet on blood pressure and plasma amino acids in older adults with knee osteoarthritis undergoing total knee arthroplasty.\n\nStudy design: Multi-center, randomized, controlled trial with an intervention and a control group.\n\nStudy population: 40 older adults (60 - 80 years) with osteoarthritis of the knee undergoing total knee replacement.\n\nIntervention: Controlled vegan diet versus controlled omnivorous diet, for a duration of 14 days.\n\nMain study parameters/endpoints: Primary study parameters are protein synthesis rates of Hoffa's fat pad, synovium, tendon, bone, ligament, menisci, and cartilage. Secondary parameters include blood pressure and plasma amino acids."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent;\n* Patients scheduled for total knee arthroplasty;\n* BMI between 20-32 kg/m2;\n* Aged 60 - 80 years;\n* Mentally competent, as judged by the treating physician;\n\nExclusion Criteria:\n\n* Following a vegetarian or vegan diet or a diet that affects protein intake during the six months prior to the study;\n* Participating in a structured progressive exercise training program in the past three months;\n* Lost more than 4 kg body weight during three months prior to the study;\n* Chronic use of medications that affect protein metabolism (i.e. systemic corticosteroids, or prescription strength acne medications);\n* Being diagnosed with one of the following: diabetes mellitus, rheumatoid arthritis, peripheral artery disease Fontaine III or IV, COPD GOLD III or IV, neoadjuvant chemotherapy or radiotherapy, phenylketonuria, collagen disorders (e.g. Marfan and Ehler-Danlos);\n* Alcohol abuse;\n* Surgical intervention to the knee in the past four weeks;\n* Total parenteral nutrition at day of surgery;\n* Glomerular filtration rate (GFR) \\<20 mL/min/1.73 m2;\n* Allergic or intolerant to any product included in the diets;\n* Osteoarthritis of the knee secondary to septic arthritis, osteonecrosis, fracture, osteochondritis dissecans, or malignant processes;\n* Any other medical condition that may interfere with the safety of the participants or the outcome parameters, in the investigators judgement;\n* Not willing to stop nutritional supplements, with the exception of vitamin D and supplements on medical advice.\n* Investigator's uncertainty about the willingness or ability of the participant to comply with the protocol instructions;\n* Participation in other studies that may have an impact on the outcomes during the three months before the start of the current study."}, 'identificationModule': {'nctId': 'NCT06130956', 'acronym': 'KneeT-vegan', 'briefTitle': 'The Effect of a 2-week Preoperative Vegan Diet Versus Omnivorous Diet on the Protein Turnover in the Osteoarthritic Knee', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Effect of a 2-week Preoperative Vegan Diet Versus Omnivorous Diet on the Protein Turnover in the Osteoarthritic Knee', 'orgStudyIdInfo': {'id': '2022023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vegan group', 'description': 'Subjects in the vegan group will receive a vegan diet during the 2-week preoperative period.', 'interventionNames': ['Dietary Supplement: Vegan diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omnivorous group', 'description': 'Subjects in the omnivorous group will receive an omnivorous diet during the 2-week preoperative period.', 'interventionNames': ['Dietary Supplement: Omnivorous diet']}], 'interventions': [{'name': 'Vegan diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vegan diet for 2 weeks before surgery', 'armGroupLabels': ['Vegan group']}, {'name': 'Omnivorous diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Omnivorous diet for 2 weeks before surgery', 'armGroupLabels': ['Omnivorous group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Inge Groenendijk', 'role': 'CONTACT', 'email': 'inge.groenendijk@wur.nl', 'phone': '0628748271'}], 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Ede', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Inge Groenendijk', 'role': 'CONTACT', 'email': 'inge.groenendijk@wur.nl', 'phone': '0628748271'}], 'facility': 'Hospital Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}], 'centralContacts': [{'name': 'Inge Groenendijk, PhD', 'role': 'CONTACT', 'email': 'inge.groenendijk@wur.nl', 'phone': '+31628748271'}, {'name': 'Lisette de Groot, PhD', 'role': 'CONTACT', 'email': 'lisette.degroot@wur.nl'}], 'overallOfficials': [{'name': 'Lisette de Groot, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gelderse Vallei Hospital', 'class': 'OTHER'}, {'name': 'Rijnstate Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof.dr.ir.', 'investigatorFullName': 'Lisette de Groot', 'investigatorAffiliation': 'Wageningen University'}}}}