Oral β-Alanine Supplementation in Patients With COPD: Structural, Metabolic and Functional Adaptations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- muscle carnosine
研究概览
简要总结
Preliminary evidence suggest that patients with chronic obstructive pulmonary disease (COPD) suffer from lower-limb muscle dysfunction. This may, at least in part, be due to a combination of physical inactivity and muscle oxidative stress. Pilot data (not published) clearly show that patients with COPD have significantly lower carnosine, which is a pH (acidity-basicity level) buffer and antioxidant, levels in the m. vastus lateralis compared to healthy subjects. Beta-alanine supplementation has shown to increase muscle carnosine in trained and untrained healthy subjects. This study will assess if muscle carnosine can be augmented by beta-alanine supplementation in 40 COPD patients (20 patients receive beta-alanine, 20 patients receive placebo). 10 healthy elderly controls will also be assessed to compare baseline muscle carnosine levels.
The aims of this study are to:
- Investigate baseline muscle carnosine levels to confirm the pilot data in a larger sample of patients with COPD compared with healthy elderly subjects
- Investigate if beta-alanine supplementation augments muscle carnosine in COPD patients and whether it has an influence on exercise capacity, lower-limb muscle function and quality of life
- To investigate baseline and post supplementation structural and metabolic muscle characteristics and markers of oxidative stress and inflammation in COPD patients and it's association with muscle carnosine levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COPD: diagnosis of moderate to very severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
- •Healthy controls: forced expiratory volume at one second/forced vital capacity (FEV1/FVC) > 0.7, matched for age and gender
排除标准
- •The presence of known instable cardiac disease
- •neurological disease and/or musculoskeletal disease that preclude safe participation in an exercise test
- •a history of drugs/alcohol abuse
- •vegetarianism
- •inability to understand the Flemish language.
- •COPD-specific exclusion criteria:
- •COPD exacerbation and/or hospitalization in the last 6 weeks
- •participation in pulmonary rehabilitation in the previous 12 months.
研究组 & 干预措施
Healthy controls
干预措施: control (Other)
COPD (placebo)
干预措施: placebo (Dietary Supplement)
COPD (beta-alanine)
干预措施: beta-alanine (Dietary Supplement)
结局指标
主要结局
muscle carnosine
时间窗: change from baseline to 12 weeks
by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy
maximal exercise capacity
时间窗: change from baseline to 12 weeks
by means of an incremental maximal cycle test
submaximal exercise capacity
时间窗: change from baseline to 12 weeks
by means of a constant-work rate cycle test
次要结局
- Functional exercise test 2(change from baseline to 12 weeks)
- Muscle function hand grip(change from baseline to 12 weeks)
- Functional exercise test 1(change from baseline to 12 weeks)
- Muscle function quadriceps(change from baseline to 12 weeks)
- Blood parameters maximal exercise test(change from baseline to 12 weeks)
- Quality of life: general(change from baseline to 12 weeks)
- Respiratory muscle function(change from baseline to 12 weeks)
- Comorbidities: ankle-brachial pressure index(change from baseline to 12 weeks)
- Comorbidities body composition 1(change from baseline to 12 weeks)
- Comorbidities(change from baseline to 12 weeks)
- Physical activity: questionnaire 1(change from baseline to 12 weeks)
- Lung function(change from baseline to 12 weeks)
- Muscle characteristics(change from baseline to 12 weeks)
- Comorbidities blood pressure(change from baseline to 12 weeks)
- Quality of life: fatigue(change from baseline to 12 weeks)
- Blood parameters submaximal exercise test(change from baseline to 12 weeks)
- Blood parameters fasted state(change from baseline to 12 weeks)
- Quality of life: dyspnea(change from baseline to 12 weeks)
- Heart function(change from baseline to 12 weeks)
- Comorbidities body composition 2(change from baseline to 12 weeks)
- Quality of life: anxiety and depression(change from baseline to 12 weeks)
- Physical activity: accelerometer(change from baseline to 12 weeks)
- Physical activity: questionnaire 2(change from baseline to 12 weeks)
- Quality of life: COPD(change from baseline to 12 weeks)
研究者
Martijn Spruit
prof. dr.
Hasselt University