The Effect of the Nutraceutical (-)- Epicatechin on Myosteatosis in Patients With Advanced CKD: a Pilot Study (EPIC-CKD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Epicatechin supplementation effect on myosteatosis
研究概览
简要总结
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.
详细描述
The effect of ageing and chronic diseases on the skeletal muscle is of great interest for studies in clinical nutrition. In the setting of chronic kidney disease (CKD), CKD-related metabolic alterations act synergistically with other risk factors in the deterioration of muscle health. Loss of muscle mass and the replacement of contractile muscle fibers by adipose tissue (i.e. myosteatosis) have been shown to decrease muscle strength and function and have a negative effect on patient centred outcomes, such as quality of life.
Considering that patients with low strength have an increased risk of falling, less independency to perform routine tasks and are more vulnerable to stressors with increased risk for recurring hospitalizations, infections, and mortality, it is of utmost importance to explore treatment strategies to overcome muscle abnormalities while improving function. Recently, interventional trials using the nutraceutical (-)- Epicatechin, an abundant flavanol present in cacao and green tea, showed an increase in skeletal muscle mass and exercise capacity through stimulating mitochondrial biogenesis. On this regard, this pilot study aims to evaluate if 100mg of (-)- Epicatechin can help ameliorate muscle abnormalities in patients with CKD.
Aims: This study aims:
- To evaluate the effect of nutraceutical (-)- Epicatechin on myosteatosis and functional capacity of patients with advanced CKD.
- To evaluate the effect of nutraceutical (-)- Epicatechin on markers of muscle regeneration.
- To evaluate the effect of nutraceutical (-)- Epicatechin on markers of mitochondrial dysfunction
This project is a feasibility pilot study to test the effect of the nutraceutical (-)- Epicatechin on muscle health. To allow for a control phase, this study has a cross-over with open label design. We here describe the methodological approach that will allow us to achieve the proposed aims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Epicatechin supplementation effect on myosteatosis
时间窗: 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
时间窗: 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).
次要结局
- 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.)
研究者
Alice Sabatino
Research Specialist
Karolinska Institutet