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NCT06631820Recruiting

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

The Effect of the Nutraceutical (-)- Epicatechin on Myosteatosis in Patients With Advanced CKD: a Pilot Study (EPIC-CKD)

Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
3 Oct 2024
Start date
17 Jan 2025
Primary completion date
Jan 2026
Lead sponsor
Karolinska Institutet
NCT number
NCT06631820

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 17 Jan 2025 to the primary completion date, Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • use of steroids medication

Other illness

  • signs of active infection
  • type 1 diabetes
  • patients with deambulatory impairment (wheelchair users, bed rest)
  • with advanced neurological disorders
  • with active cancer diagnosis

Other

  • acute vasculitis
  • transplanted patients
  • patients on compassionate care for the end of life
  • with cognitive impairments
  • participation in another interventional trial.

Who the study is looking for

  • 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

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Karolinska University Hospital
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HuddingeSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.