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

NCT06631820 | Recruiting

• 1 other identifier: 2024-04198-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

myosteatosis; epicatechin; nutraceuticals; chronic kidney disease; mitochondrial dysfunction; muscle regeneration; muscle function

Outcome Measures

Primary Outcomes (2)

• Epicatechin supplementation effect on myosteatosis

  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.

  At enrolment, at 8 weeks from enrolment and at 16 weeks from enrolment.

• Epicatechin supplementation effect on muscle function

  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).

  At enrolment, at 8 weeks from enrolment and at 16 weeks from enrolment.

Secondary Outcomes (2)

• Epicatechin supplementation effect on markers of muscle regeneration

  At enrolment, at 8 weeks from enrolment and at 16 weeks from enrolment.

• Epicatechin supplementation effect on markers of mitochondrial dysfunction

  At enrolment, at 8 weeks from enrolment and at 16 weeks from enrolment.

Study Arms (2)

control phase

NO INTERVENTION

patients will undergo 8 weeks without the supplement after enrolment to allow for a control phase

experimental phase

EXPERIMENTAL

after 8 weeks of control phase, patients will receive the supplement for 8 weeks

Dietary Supplement: Epicatechin extract

Interventions

Epicatechin extract DIETARY_SUPPLEMENT

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.

experimental phase

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Huddinge, Stockholm County, 14152, Sweden

RECRUITING

Related Publications (5)

• Gamboa JL, Roshanravan B, Towse T, Keller CA, Falck AM, Yu C, Frontera WR, Brown NJ, Ikizler TA. Skeletal Muscle Mitochondrial Dysfunction Is Present in Patients with CKD before Initiation of Maintenance Hemodialysis. Clin J Am Soc Nephrol. 2020 Jul 1;15(7):926-936. doi: 10.2215/CJN.10320819. Epub 2020 Jun 26.

  PMID: 32591419 BACKGROUND

• Gamboa JL, Billings FT 4th, Bojanowski MT, Gilliam LA, Yu C, Roshanravan B, Roberts LJ 2nd, Himmelfarb J, Ikizler TA, Brown NJ. Mitochondrial dysfunction and oxidative stress in patients with chronic kidney disease. Physiol Rep. 2016 May;4(9):e12780. doi: 10.14814/phy2.12780.

  PMID: 27162261 BACKGROUND

• Avesani CM, de Abreu AM, Ribeiro HS, Brismar TB, Stenvinkel P, Sabatino A, Lindholm B. Muscle fat infiltration in chronic kidney disease: a marker related to muscle quality, muscle strength and sarcopenia. J Nephrol. 2023 Apr;36(3):895-910. doi: 10.1007/s40620-022-01553-0. Epub 2023 Jan 31.

  PMID: 36719556 BACKGROUND

• McDonald CM, Ramirez-Sanchez I, Oskarsson B, Joyce N, Aguilar C, Nicorici A, Dayan J, Goude E, Abresch RT, Villarreal F, Ceballos G, Perkins G, Dugar S, Schreiner G, Henricson EK. (-)-Epicatechin induces mitochondrial biogenesis and markers of muscle regeneration in adults with Becker muscular dystrophy. Muscle Nerve. 2021 Feb;63(2):239-249. doi: 10.1002/mus.27108. Epub 2020 Dec 16.

  PMID: 33125736 BACKGROUND

• Taub PR, Ramirez-Sanchez I, Ciaraldi TP, Gonzalez-Basurto S, Coral-Vazquez R, Perkins G, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. Perturbations in skeletal muscle sarcomere structure in patients with heart failure and type 2 diabetes: restorative effects of (-)-epicatechin-rich cocoa. Clin Sci (Lond). 2013 Oct;125(8):383-9. doi: 10.1042/CS20130023.

  PMID: 23642227 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Mitochondrial Diseases

Interventions

Catechin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonoids; Chromones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Alice Sabatino, PhD

CONTACT

+460762931786; alice.sabatino@ki.se

Peter Stenvinkel, PhD

CONTACT

+46852482876; peter.stenvinkel@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Specialist

Model Details: This is a pilot treatment crossover interventional trial

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: January 17, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

SE (1)