RecruitingPhase 3NCT06329622

Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease

Ketosteril Sarcopenia Chronic Kidney Disease


Sponsor

Huashan Hospital

Enrollment

58 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement called Ketosteril (a combination of amino acid building blocks) can help people with chronic kidney disease (CKD) who are also experiencing muscle loss and weakness — a condition known as sarcopenia. Muscle loss is common in people with CKD and can significantly affect quality of life. Researchers want to see if Ketosteril can help preserve or restore muscle strength and function. **You may be eligible if:** - You have been diagnosed with stage 3 or 4 chronic kidney disease (moderate to severe) - You have been diagnosed with sarcopenia, meaning you have reduced muscle mass AND either weak grip strength or difficulty walking or standing up from a chair - You are able to walk independently **You may NOT be eligible if:** - You have diabetes - You are overweight or obese (BMI greater than 25) - You have previously had kidney dialysis or a kidney transplant - You had a major heart event or uncontrolled heart failure in the last 3 months - You have an active infection or uncontrolled flare-up of another illness - You have had a stroke, severe liver disease, cancer, or multiple organ failure - You have joint disease, bone disease, paralysis, or significant cognitive decline that limits movement - You have high blood calcium levels or amino acid metabolism disorders - You are allergic to any ingredient in Ketosteril - You participated in another clinical trial in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTlow-protein diet + Ketosteril

low-protein diet (0.6-0.8g protein/kg body weight/day) and Ketosteril 0.12 g/kg body weight/day will be prescribed with the target energy intake of 25-30kcal/kg body weight/day.

DIETARY_SUPPLEMENTlow-protein diet

low-protein diet (0.6-0.8g protein/kg body weight/day) with the target energy intake of 25-30kcal/kg body weight/day.


Locations(1)

Huashan hospital, Fudan university

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06329622


Related Trials