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:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT06287502
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of sarcopenia:
* Low hand grip strength (Male: \<28 kg, Female: \<18 kg) AND
* Low appendicular skeletal mass by bioimpedance analysis (Male: \<7.0 kg/m2 Female: \<5.7 kg/m2)
2. Diagnosed with osteoporosis by:
* Fragility fracture or
* T-score ≤-2.5 SDs at any site based upon BMD measurement by Dual Energy X-ray Absorptiometry (DXA) scan
Exclusion Criteria:
1. Incompetent in giving consent or following commands
2. Non-ambulatory subject
3. Unstable medical conditions contributing to sarcopenia, for example but not limited to:
1. End stage organ failure
2. Unstable cardiovascular, respiratory, gastrointestinal and endocrine conditions
3. Active malignancy
4. Chronic kidney disease stage IV or above or with hyperkalaemia
5. Diabetes mellitus on medications or with unstable control
6. Terminal illness
7. Obese subjects (BMI ≥ 25.0)
8. Self-reported allergy to the ingredients of the nutrition supplement
9. Patients with metallic implants
10. Any orthopaedic pathologies affecting the strength of bilateral upper limbs
11. Any hereditary or acquired muscular diseases
12. Participation in other regular exercise programme
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06287502
Study Brief:
Protocol Section:
NCT06287502