The effect of a 2-week preoperative vegan diet versus omnivorous diet on the protein turnover in the osteoarthritic knee
- Conditions
- knee wear and tearosteoarthritis in the knee10043237
- Registration Number
- NL-OMON56530
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
- Written informed consent;
- Male and female patients scheduled for total knee arthroplasty;
- BMI between 20-32 kg/m2;
- Aged 60 - 80 years;
- Mentally competent, as judged by the treating physician.
- 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 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,
phenylketonuria, collagen disorders (e.g. Marfan and Ehler-Danlos);
- Receiving neoadjuvant chemotherapy or radiotherapy;
- Alcohol abuse (for men 15 or more alcoholic drinks per week and for women 8
or more alcoholic drinks per week);
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters are protein synthesis rates of Hoffa*s fat pad,<br /><br>synovium, bone, ligament, menisci, and cartilage. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters include blood pressure, and plasma amino acids.</p><br>