The Effect of the Nutraceutical (-)- Epicatechin on Myosteatosis in Patients With Advanced CKD

Recruiting now · Not applicable

Conditions studied: Chronic Kidney Disease(CKD), Myosteatosis, Mitochondrial Dysfunction, Muscle Function, Muscle Mass

In brief

Some foods have components that can prevent and treat some diseases and provide beneficial effects for health. These components naturally occurring in foods are called nutraceuticals. Recently, it was found that Epicatechin, which is a kind of nutraceutical from the Catechin's family naturally occurring in green tea and cocoa, has positive effects on muscle mass and strength of people with chronic diseases. People with chronic kidney disease often present muscle loss and lack of strength that are not easily treated with regular diet and physical activity. We here propose a study where 10 individuals with chronic kidney disease will receive a dose of Epicatechin for 8 weeks and we aim to test if Epicatechin improves general muscle health. Based on what is known, we expect to see an increase in muscle mass and strength. The dose of Epicatechin provided (100 mg/day) is safe, since it is much lower than the dose usually available in supplements. In addition, this is the form naturally present in green tea and cocoa and in similar amounts. Subjects participating in the study will be evaluated for muscle mass and strength three times during the study. Muscle mass and muscle quality will be evaluated by ultrasound and magnetic resonance imaging. The participants will also perform some tests like walking in a corridor and seating and standing from a chair to measure their strength and performance. Adverse side effects will be monitored via telephone, and safety will be assessed by monthly blood tests that will evaluate liver and kidney function. If this study shows that Epicatechin can promote muscle growth and strength, it will positively affect patients with chronic kidney disease that might benefit of a natural substance from food to improve muscle health.

Key facts

Study ID

NCT06631820

Run by

Karolinska Institutet

People needed

10

Starts

2025-01-17

Expected to finish

2026-10-01

Last updated by the study team

2025-07-10

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• estimated glomerular filtration rate (eGFR) < 29 ml/min/1.75m2
• no chronic or acute known liver disease
• not intended to initiate renal replacement therapy treatment in the next 4 months according to nephrologist clinical judgment

You may not qualify if…

• signs of active infection
• acute vasculitis
• type 1 diabetes
• use of steroids medication
• transplanted patients
• patients with deambulatory impairment (wheelchair users, bed rest)
• patients on compassionate care for the end of life
• with advanced neurological disorders
• with cognitive impairments
• with active cancer diagnosis
• participation in another interventional trial.

Where it is running

• Karolinska University Hospital — Huddinge, Stockholm County, Sweden (enrolling)

Full record on ClinicalTrials.gov

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