Status:
RECRUITING
The Effect of a 2-week Preoperative Vegan Diet Versus Omnivorous Diet on the Protein Turnover in the Osteoarthritic Knee
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Gelderse Vallei Hospital
Rijnstate Hospital
Conditions:
Osteo Arthritis Knee
Protein Synthesis
Eligibility:
All Genders
60-80 years
Phase:
NA
Brief Summary
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 pr...
Eligibility Criteria
Inclusion
- Written informed consent;
- Patients scheduled for total knee arthroplasty;
- BMI between 20-32 kg/m2;
- Aged 60 - 80 years;
- Mentally competent, as judged by the treating physician;
Exclusion
- Following a vegetarian or vegan diet or a diet that affects protein intake during the six months prior to the study;
- Participating in a structured progressive exercise training program in the past three months;
- Lost more than 4 kg body weight during three months prior to the study;
- Chronic use of medications that affect protein metabolism (i.e. systemic corticosteroids, or prescription strength acne medications);
- 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);
- Alcohol abuse;
- Surgical intervention to the knee in the past four weeks;
- Total parenteral nutrition at day of surgery;
- Glomerular filtration rate (GFR) \<20 mL/min/1.73 m2;
- Allergic or intolerant to any product included in the diets;
- Osteoarthritis of the knee secondary to septic arthritis, osteonecrosis, fracture, osteochondritis dissecans, or malignant processes;
- Any other medical condition that may interfere with the safety of the participants or the outcome parameters, in the investigators judgement;
- Not willing to stop nutritional supplements, with the exception of vitamin D and supplements on medical advice.
- Investigator's uncertainty about the willingness or ability of the participant to comply with the protocol instructions;
- Participation in other studies that may have an impact on the outcomes during the three months before the start of the current study.
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06130956
Start Date
October 22 2024
End Date
December 1 2026
Last Update
April 1 2025
Active Locations (2)
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1
Rijnstate Hospital
Arnhem, Netherlands
2
Hospital Gelderse Vallei
Ede, Netherlands