Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT06631820

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

Led by Karolinska Institutet · Updated on 2025-07-10

10

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Estimated glomerular filtration rate (eGFR) less than 29 ml/min/1.75m2
  • No known chronic or acute liver disease
  • Not expected to start renal replacement therapy in the next 4 months according to nephrologist judgment
Not Eligible

You will not qualify if you...

  • Signs of active infection
  • Acute vasculitis
  • Type 1 diabetes
  • Use of steroid medications
  • Transplanted patients
  • Patients with walking impairment (wheelchair users, bed rest)
  • Patients receiving compassionate care for end of life
  • Advanced neurological disorders
  • Cognitive impairments
  • Active cancer diagnosis
  • Participation in another interventional trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

Karolinska University Hospital

Huddinge, Stockholm County, Sweden, 14152

Actively Recruiting

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Research Team

A

Alice Sabatino, PhD

CONTACT

P

Peter Stenvinkel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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