Epicatechin for muscle fat and weakness in advanced chronic kidney disease
The Effect of the Nutraceutical (-)- Epicatechin on Myosteatosis in Patients With Advanced CKD: a Pilot Study (EPIC-CKD)
This study will give 100 mg/day of the nutraceutical epicatechin for 8 weeks to people with advanced CKD to see if it increases muscle mass, reduces fat in muscle, and improves strength.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge, Stockholm County) |
| Trial ID | NCT06631820 on ClinicalTrials.gov |
What this trial studies
This is a small, open-label pilot interventional trial where 10 participants with advanced chronic kidney disease (eGFR <29 mL/min/1.73m2) will receive 100 mg/day of (-)-epicatechin for 8 weeks. The study will measure changes in myosteatosis, muscle mass, and functional capacity using imaging and physical performance tests, alongside laboratory markers related to mitochondrial function. Safety and tolerability will be monitored, and common exclusions include active infection, type 1 diabetes, recent steroid use, active cancer, transplant recipients, and major mobility or cognitive impairments. The dose chosen is lower than that found in many supplements and is considered safe based on existing data.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced CKD (eGFR <29 mL/min/1.73m2) who are not expected to start renal replacement therapy within four months, have no known liver disease, and are able to ambulate and provide consent.
Not a fit: Patients with type 1 diabetes, active infections or vasculitis, active cancer, recent steroid use, prior transplant, severe mobility or cognitive impairments, or those on imminent end-of-life/compassionate care are excluded and unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, epicatechin could increase muscle mass and strength and reduce fat infiltration in muscle, which may improve physical function and quality of life for people with advanced CKD.
How similar studies have performed: Previous interventional trials of (-)-epicatechin have reported increases in skeletal muscle mass and exercise capacity linked to stimulated mitochondrial biogenesis, so this pilot builds on promising but limited evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Huddinge, Stockholm County
- Karolinska University Hospital — Huddinge, Stockholm County, Sweden (Recruiting)
Study contacts
- Study coordinator: Alice Sabatino, PhD
- Email: alice.sabatino@ki.se
- Phone: +460762931786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.