Chronic Kidney Disease(CKD)MyosteatosisMitochondrial DysfunctionMuscle FunctionMuscle Mass
Investigational drug(s) / intervention(s)
Epicatechin extract
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.
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.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Epicatechin supplementation effect on myosteatosis — At enrolment, at 8 weeks from enrolment and at 16 weeks from enrolment. Myosteatosis will be evaluated by Ultrasound (US) and Magnetic resonance imaging (MRI).
US: We will use a B-mode wall tracking US device (Clarius, Vancouver, Canada).Two muscles will be identified, the rectus femoris and vastus intermedius. The collected images will allow us to measure muscle thickness, rectus femoris cross-sectional area, rectus femoris and vastus intermedius echogenicity. While thickness and cross-sectional area provide information on muscle quantity, the echogenicity of the muscle provides information on myosteatosis.
MRI: We will evaluate rectus femoris volume, rectus femoris and vastus intermedius thickness, and rectus femoris cross-sectional area to evaluate muscle quantity. Myosteatosis will be evaluated by applying quantitative fat water imaging (Dixon imaging), information on intermuscular adipose tissue (IMAT), intramuscular adipose tissue, and average myosteatosis level will be performed by experienced radiologist.
Epicatechin supplementation effect on muscle function — At enrolment, at 8 weeks from enrolment and at 16 weeks from enrolment. Functional tests: Strength will be assessed by handgrip strength using a portable dynamometer, and by the chair stand test (5 time sit to stand and 30 seconds sit-to stand test). Performance will be assessed by the gait speed test, that evaluates the normal speed that a person usually walks and by the 6 minutes walking distance test. An integrated functional test called Short Physical Performance Battery (SPPB), will be used (at baseline, week 8 and week 16).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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