NL-OMON56530尚未招募不适用
The effect of a 2-week preoperative vegan diet versus omnivorous diet on the protein turnover in the osteoarthritic knee - KneeT-vegan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 至 99（—）
入选标准
- •- 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.
排除标准
- •- 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
- •- 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.
研究者
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