NCT06631820 The Effect of the Nutraceutical (-)- Epicatechin on Myosteatosis in Patients With Advanced CKD
| NCT ID | NCT06631820 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Chronic Kidney Disease(CKD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-01-17 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06631820 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Chronic Kidney Disease(CKD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06631820 currently recruiting?
Yes, NCT06631820 is actively recruiting participants. Contact the research team at alice.sabatino@ki.se for enrollment information.
Where is the NCT06631820 trial being conducted?
This trial is being conducted at Huddinge, Sweden.
Who is sponsoring the NCT06631820 clinical trial?
NCT06631820 is sponsored by Karolinska Institutet. The trial plans to enroll 10 participants.
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