Anti-sarcopenic Effect of Leucine Supplementation in Elderly Chronic Kidney Disease Patients: A Double-Blinded Randomized Controlled Trial

Phase 1

Recruiting

• Conditions: CKD stage III and IV patients with aged over 65 yrs; Sarcopenia, Leucine, Muscle wasting, Muscle mass, Chronic kidney disease

• Registration Number: TCTR20200314003
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-14
• Study Completion: 2020-04-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age >65 years old
eGFR 30-59 ml/min/1.73m2
Signed informed consent
No contraindication for leucine

Exclusion Criteria

Catabolic stage
Active infection
Active malignancy
Diabetes
Liver disease
Vascular disease
Cardiac abnormalities
Metabolic disease or injury
No history of steroid used

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the effect of 12-weeks leucine supplementation on muscle mass and protein synthesis i at 12 weeks after start of the intervention Lean muscle mass form DXA Scan

Secondary Outcome Measures

Name	Time	Method
Risk factors of sarcopenia in elderly chronic kidney disease patients at 12 weeks after start of the intervention Laboratory profile