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| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD (beta-alanine) | Active Comparator |
| |
| COPD (placebo) | Placebo Comparator |
| |
| Healthy controls | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beta-alanine | Dietary Supplement | Patients receive beta-alanine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| muscle carnosine | by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy | change from baseline to 12 weeks |
| maximal exercise capacity | by means of an incremental maximal cycle test | change from baseline to 12 weeks |
| submaximal exercise capacity | by means of a constant-work rate cycle test | change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional exercise test 1 | by means of a 6 minutes walk test | change from baseline to 12 weeks |
| Functional exercise test 2 | by means of a 4 meter gait test |
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Inclusion Criteria:
Exclusion Criteria:
COPD-specific exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martijn Spruit, prof. dr. | Hasselt University | Principal Investigator |
| Jana De Brandt, drs | Hasselt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis (ReGo) | Hasselt | 3500 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35977911 | Derived | De Brandt J, Derave W, Vandenabeele F, Pomies P, Blancquaert L, Keytsman C, Barusso-Gruninger MS, de Lima FF, Hayot M, Spruit MA, Burtin C. Efficacy of 12 weeks oral beta-alanine supplementation in patients with chronic obstructive pulmonary disease: a double-blind, randomized, placebo-controlled trial. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2361-2372. doi: 10.1002/jcsm.13048. Epub 2022 Aug 17. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D015091 | beta-Alanine |
| ID | Term |
|---|---|
| D000409 | Alanine |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| placebo |
| Dietary Supplement |
Patients receive placebo |
|
| control | Other | Healthy controls will be assessed to compare baseline muscle carnosine levels |
|
| change from baseline to 12 weeks |
| Muscle function quadriceps | by means of measuring quadriceps (isometric and isokinetic knee extension-flexion) | change from baseline to 12 weeks |
| Respiratory muscle function | by means of measuring respiratory muscle strength (maximal inspiratory and expiratory pressure) | change from baseline to 12 weeks |
| Muscle function hand grip | by means of measuring hand grip strength | change from baseline to 12 weeks |
| Muscle characteristics | Structural and metabolic parameters will be measured with dedicated methodology | change from baseline to 12 weeks |
| Blood parameters submaximal exercise test | by means of obtaining venous blood before, during and after the constant-work rate cycle test. Blood parameters will be measured with dedicated methodology. | change from baseline to 12 weeks |
| Blood parameters fasted state | by means of obtaining fasting venous blood. Blood parameters will be measured with dedicated methodology. | change from baseline to 12 weeks |
| Blood parameters maximal exercise test | by means of obtaining venous blood before and after the maximal cycle test. Blood parameters will be measured with dedicated methodology. | change from baseline to 12 weeks |
| Comorbidities | by means of Charlson Morbidity index | change from baseline to 12 weeks |
| Comorbidities: ankle-brachial pressure index | by means of ankle-brachial pressure index | change from baseline to 12 weeks |
| Comorbidities blood pressure | by means of resting systolic and diastolic blood pressure | change from baseline to 12 weeks |
| Comorbidities body composition 1 | by means of bio-electrical impedance | change from baseline to 12 weeks |
| Comorbidities body composition 2 | by means of whole body dual X-ray absorptiometry | change from baseline to 12 weeks |
| Quality of life: anxiety and depression | by means of the "Hospital Anxiety and Depression Scale" | change from baseline to 12 weeks |
| Quality of life: fatigue | by means of the "Multidimensional Fatigue Inventory" | change from baseline to 12 weeks |
| Quality of life: dyspnea | by means of the " Modified Medical Research Council (MMRC) dyspnea grade" | change from baseline to 12 weeks |
| Quality of life: general | by means of the "Euroqol 5 dimensions (EQ-5D) generic questionnaire" | change from baseline to 12 weeks |
| Quality of life: COPD | by means of the "COPD assessment test" | change from baseline to 12 weeks |
| Physical activity: accelerometer | by means of physical activity monitoring via Actigraph (accelerometer) | change from baseline to 12 weeks |
| Physical activity: questionnaire 1 | by means of physical activity monitoring via "Behavioural Regulation in Exercise Questionnaire" | change from baseline to 12 weeks |
| Physical activity: questionnaire 2 | by means of physical activity monitoring via "Modified Baecke questionnaire" | change from baseline to 12 weeks |
| Lung function | by means of general pulmonary function (spirometry, long volumes, diffusion capacity for carbon monoxide). | change from baseline to 12 weeks |
| Heart function | by means of resting ECG testing | change from baseline to 12 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |