The Effect of Resveratrol on Metabolism and Cardiovascular Risk Profile in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in mitochondrial function
研究概览
简要总结
The primary objective is to investigate the efficacy of resveratrol on mitochondrial function in patients with COPD. The secondary objective is to investigate the effect of resveratrol on body composition, inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a comprehensive assessment of metabolicand physical performance profile known to be affected by resveratrol.
详细描述
Rationale: Patients with COPD are often chaacterized by disturbed metabolic health affecting physical and cognitive function, which is reflected in altered body composition. current studies in healthy subjects suggest that resveratrol improves metabolic health by enhancing muscle mitochondrial function and adipose tissue morphology.
Study design: Proof-of-concept randomized placebo-controlled double blinded clinical trial of 4 weeks.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects may be confronted with certain inconveniences and risks. Subjects will be asked to wear an accelerometer two times for one week. During the entire study period subjects will visit the MUMC+ 2 times for various non-invasive measurements (questionnaires, anthropometry, and physical function test) as well as some minor invasive procedures (venous blood sampling and muscle and fat biopsies) which can cause a local haematoma afterwards. However, the patients will be informed about their metabolic and cardiovascular health, which we expect to be positively affected by the intervention. In addition, all patients will receive a lifestyle advice tailored to their health status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients
- •Current or ex-smoker
- •Age >18 years
排除标准
- •COPD patients planned for pulmonary rehabilitation or who recently participated in a rehabilitation program in the previous 6 months
- •Investigator's uncertainty about willingness or ability of the patient to comply with the protocol requirements
- •Participation in any other study involving investigational exercise training, nutritional or pharmacological intervention
- •Oral glucocorticoid use
- •Recent exacerbation (<4 weeks) that required oral steroids and/or hospital admission
- •Subject is pregnant, planning to be pregnant during the study period, lactating, or women who consider themselves to be of childbearing potential and who are engaged in an active sex life and are unwilling to commit to the use of an approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation;
- •Diabetes mellitus (all types), active cardiovascular disease or a cardiovascular event (such as myocardial infarction, cerebrovascular haemorrhage/infarction) in the previous 6 months, recent major surgery, thyroid dysfunction, hepatic or renal disorders, current malignancy (except for dermal malignancies) or central or obstructive sleep apnea;
- •Current alcohol consumption > 20 grams alcohol/day;
- •Intake of resveratrol containing dietary supplements.
研究组 & 干预措施
Resveratrol supplementation
150 mg of resveratrol for 4 weeks (split over two doses of 75 mg/day)
干预措施: Resveratrol (Dietary Supplement)
Placebo supplementation
Placebo for 4 weeks (split over two doses per day)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in mitochondrial function
时间窗: 0 and 4 weeks
Assessed by measuring mitochondrial respiration (using the oxygraph) of a muscle biopsy of the quadriceps muscle (vastus lateralis)
次要结局
- Change in lipid profile(0 and 4 weeks)
- Change in insulin sensitivity(0 and 4 weeks)
- Change from baseline in high sensitivity systemic inflammation (CRP) at 4 weeks(0 and 4 weeks)
- Change in adipose tissue inflammation(0 and 4 weeks)
- Change in systematic inflammatory profile(0 and 4 weeks)
- Change in quadriceps function(0 and 4weeks)
- Change in blood pressure(0 and 4 weeks)
- Change in heart rate(0 and 4 weeks)
- Change in body composition(0 and 4 weeks)