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Oral β-Alanine Supplementation in Patients With COPD

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赞助商
Hasselt University
合作者
Jessa Hospital

关键词

抽象

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:
1. Investigate baseline muscle carnosine levels to confirm the pilot data in a larger sample of patients with COPD compared with healthy elderly subjects
2. 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
3. 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

日期

最后验证: 01/31/2019
首次提交: 05/08/2016
提交的预估入学人数: 05/10/2016
首次发布: 05/11/2016
上次提交的更新: 02/20/2019
最近更新发布: 02/21/2019
实际学习开始日期: 04/30/2016
预计主要完成日期: 01/31/2019
预计完成日期: 01/31/2019

状况或疾病

Chronic Obstructive Pulmonary Disease (COPD)

干预/治疗

Dietary Supplement: COPD (beta-alanine)

Dietary Supplement: COPD (placebo)

Other: Healthy controls

-

手臂组

干预/治疗
Active Comparator: COPD (beta-alanine)
Dietary Supplement: COPD (beta-alanine)
Patients receive beta-alanine
Placebo Comparator: COPD (placebo)
Dietary Supplement: COPD (placebo)
Patients receive placebo
Other: Healthy controls
Other: Healthy controls
Healthy controls will be assessed to compare baseline muscle carnosine levels

资格标准

有资格学习的年龄 40 Years 至 40 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

结果

主要结果指标

1. muscle carnosine [change from baseline to 12 weeks]

by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy

2. maximal exercise capacity [change from baseline to 12 weeks]

by means of an incremental maximal cycle test

3. submaximal exercise capacity [change from baseline to 12 weeks]

by means of a constant-work rate cycle test

次要成果指标

1. Functional exercise test 1 [change from baseline to 12 weeks]

by means of a 6 minutes walk test

2. Functional exercise test 2 [change from baseline to 12 weeks]

by means of a 4 meter gait test

3. Muscle function quadriceps [change from baseline to 12 weeks]

by means of measuring quadriceps (isometric and isokinetic knee extension-flexion)

4. Respiratory muscle function [change from baseline to 12 weeks]

by means of measuring respiratory muscle strength (maximal inspiratory and expiratory pressure)

5. Muscle function hand grip [change from baseline to 12 weeks]

by means of measuring hand grip strength

6. Muscle characteristics [change from baseline to 12 weeks]

Structural and metabolic parameters will be measured with dedicated methodology

7. Blood parameters submaximal exercise test [change from baseline to 12 weeks]

by means of obtaining venous blood before, during and after the constant-work rate cycle test. Blood parameters will be measured with dedicated methodology.

8. Blood parameters fasted state [change from baseline to 12 weeks]

by means of obtaining fasting venous blood. Blood parameters will be measured with dedicated methodology.

9. Blood parameters maximal exercise test [change from baseline to 12 weeks]

by means of obtaining venous blood before and after the maximal cycle test. Blood parameters will be measured with dedicated methodology.

10. Comorbidities [change from baseline to 12 weeks]

by means of Charlson Morbidity index

11. Comorbidities: ankle-brachial pressure index [change from baseline to 12 weeks]

by means of ankle-brachial pressure index

12. Comorbidities blood pressure [change from baseline to 12 weeks]

by means of resting systolic and diastolic blood pressure

13. Comorbidities body composition 1 [change from baseline to 12 weeks]

by means of bio-electrical impedance

14. Comorbidities body composition 2 [change from baseline to 12 weeks]

by means of whole body dual X-ray absorptiometry

15. Quality of life: anxiety and depression [change from baseline to 12 weeks]

by means of the "Hospital Anxiety and Depression Scale"

16. Quality of life: fatigue [change from baseline to 12 weeks]

by means of the "Multidimensional Fatigue Inventory"

17. Quality of life: dyspnea [change from baseline to 12 weeks]

by means of the " Modified Medical Research Council (MMRC) dyspnea grade"

18. Quality of life: general [change from baseline to 12 weeks]

by means of the "Euroqol 5 dimensions (EQ-5D) generic questionnaire"

19. Quality of life: COPD [change from baseline to 12 weeks]

by means of the "COPD assessment test"

20. Physical activity: accelerometer [change from baseline to 12 weeks]

by means of physical activity monitoring via Actigraph (accelerometer)

21. Physical activity: questionnaire 1 [change from baseline to 12 weeks]

by means of physical activity monitoring via "Behavioural Regulation in Exercise Questionnaire"

22. Physical activity: questionnaire 2 [change from baseline to 12 weeks]

by means of physical activity monitoring via "Modified Baecke questionnaire"

23. Lung function [change from baseline to 12 weeks]

by means of general pulmonary function (spirometry, long volumes, diffusion capacity for carbon monoxide).

24. Heart function [change from baseline to 12 weeks]

by means of resting ECG testing

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