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

NCT06631820 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-10

No results posted yet for this study

Summary

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

  • Chronic Kidney Disease(CKD)
  • Myosteatosis
  • Mitochondrial Dysfunction
  • Muscle Function
  • Muscle Mass

Interventions

DIETARY_SUPPLEMENT

Epicatechin extract

In the experimental phase, patients will take 50 mg of (-)- Epicatechin twice a day for 8 weeks (total dose 100mg/day). The nutraceutical will be supplied as monodose sachets from Aayam Therapeutics.Study participants will mix the sachet powder with juice (10-20mL) in the morning 15 minutes before breakfast and in the evening 15 minutes before sleeping or 1h after dinner.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2026-01-31
Completion
2026-10-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631820 on ClinicalTrials.gov