Skeletal Muscle Mitochondrial Dysfunction Is Present in Patients with CKD before Initiation of Maintenance Hemodialysis.
Jorge L Gamboa, Baback Roshanravan, Theodore Towse...
https://pubmed.ncbi.nlm.nih.gov/32591419/Actively Recruiting
Led by Karolinska Institutet · Updated on 2025-07-10
10
Participants Needed
1
Research Sites
39 weeks
Total Duration
Researchers are investigating the effects of the nutraceutical -- Epicatechin on muscle health in people with advanced chronic kidney disease CKD. CKD often leads to muscle loss and weakness due to metabolic changes and muscle tissue replacement by fat, reducing strength and quality of life. This pilot study aims to see if 100 mg per day of -- Epicatechin, a natural compound found in green tea and cocoa, can improve muscle quality, function, and regeneration in this group. The study has two phases an 8-week control period without supplementation followed by an 8-week treatment period where participants take 50 mg of -- Epicatechin twice daily, mixed with juice before meals or before sleep. A total of 10 participants will be enrolled. The nutraceutical is provided in monodose sachets, and participants are asked not to change their diet during the study. The study includes five visits over 16 weeks, with safety monitoring through blood tests and phone calls. During the study, participants will have muscle mass and quality assessed using ultrasound and MRI, and muscle strength and performance will be measured through walking and chair stand tests. Blood and urine samples will be collected to evaluate markers related to muscle regeneration and mitochondrial function. Participants will also wear activity monitors and be monitored for side effects. The main goals are to evaluate changes in muscle fat infiltration, function, and related biological markers to understand the potential benefits of -- Epicatechin for muscle health in CKD.
CONDITIONS
The Effect of the Nutraceutical (-)- Epicatechin on Myosteatosis in Patients With Advanced CKD
A
Alice Sabatino, PhD
P
Peter Stenvinkel, PhD
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Karolinska Institutet
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 1 to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants are followed without receiving the nutraceutical to serve as a control period.
1 baseline visit and 1 follow-up visit
Duration - 8 weeks
Participants take 50 mg of (-)- Epicatechin twice a day for 8 weeks to evaluate its effect on muscle health.
1 in-person visit, 1 phone call, and 1 local laboratory visit
Duration - 1 week
Participants undergo final evaluations and sampling to assess the effects of the nutraceutical.
1 in-person visit within 1 week after treatment ends
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/23642227/Karolinska Institutet
Lead Sponsor