Oral β-Alanine Supplementation in Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Dietary Supplement: beta-alanineDietary Supplement: placeboOther: control
- Registration Number
- NCT02770417
- Lead Sponsor
- Hasselt University
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COPD (beta-alanine) beta-alanine - COPD (placebo) placebo - Healthy controls control -
- Primary Outcome Measures
Name Time Method muscle carnosine change from baseline to 12 weeks by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy
maximal exercise capacity change from baseline to 12 weeks by means of an incremental maximal cycle test
submaximal exercise capacity change from baseline to 12 weeks by means of a constant-work rate cycle test
- Secondary Outcome Measures
Name Time Method Functional exercise test 2 change from baseline to 12 weeks by means of a 4 meter gait test
Muscle function hand grip change from baseline to 12 weeks by means of measuring hand grip strength
Functional exercise test 1 change from baseline to 12 weeks by means of a 6 minutes walk test
Muscle function quadriceps change from baseline to 12 weeks by means of measuring quadriceps (isometric and isokinetic knee extension-flexion)
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.
Quality of life: general change from baseline to 12 weeks by means of the "Euroqol 5 dimensions (EQ-5D) generic questionnaire"
Respiratory muscle function change from baseline to 12 weeks by means of measuring respiratory muscle strength (maximal inspiratory and expiratory pressure)
Comorbidities: ankle-brachial pressure index change from baseline to 12 weeks by means of ankle-brachial pressure index
Comorbidities body composition 1 change from baseline to 12 weeks by means of bio-electrical impedance
Comorbidities change from baseline to 12 weeks by means of Charlson Morbidity index
Physical activity: questionnaire 1 change from baseline to 12 weeks by means of physical activity monitoring via "Behavioural Regulation in Exercise Questionnaire"
Lung function change from baseline to 12 weeks by means of general pulmonary function (spirometry, long volumes, diffusion capacity for carbon monoxide).
Muscle characteristics change from baseline to 12 weeks Structural and metabolic parameters will be measured with dedicated methodology
Comorbidities blood pressure change from baseline to 12 weeks by means of resting systolic and diastolic blood pressure
Quality of life: fatigue change from baseline to 12 weeks by means of the "Multidimensional Fatigue Inventory"
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.
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.
Quality of life: dyspnea change from baseline to 12 weeks by means of the " Modified Medical Research Council (MMRC) dyspnea grade"
Heart function change from baseline to 12 weeks by means of resting ECG testing
Comorbidities body composition 2 change from baseline to 12 weeks by means of whole body dual X-ray absorptiometry
Quality of life: anxiety and depression change from baseline to 12 weeks by means of the "Hospital Anxiety and Depression Scale"
Physical activity: accelerometer change from baseline to 12 weeks by means of physical activity monitoring via Actigraph (accelerometer)
Physical activity: questionnaire 2 change from baseline to 12 weeks by means of physical activity monitoring via "Modified Baecke questionnaire"
Quality of life: COPD change from baseline to 12 weeks by means of the "COPD assessment test"
Trial Locations
- Locations (1)
Jessa Ziekenhuis (ReGo)
🇧🇪Hasselt, Belgium