Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT06130956
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT06130956
Study Brief:
Protocol Section:
NCT06130956