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Completed

NCT Number: NCT02770417

Oral β-Alanine Supplementation in Patients With COPD

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis (ReGo)

Hasselt, 3500, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beta-alanine

Dietary Supplement

Patients receive beta-alanine

Placebo

Dietary Supplement

Patients receive placebo

Control

Other

Healthy controls will be assessed to compare baseline muscle carnosine levels

Primary outcomes

  1. muscle carnosine

    Time frame: change from baseline to 12 weeks

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

  2. maximal exercise capacity

    Time frame: change from baseline to 12 weeks

    by means of an incremental maximal cycle test

  3. submaximal exercise capacity

    Time frame: change from baseline to 12 weeks

    by means of a constant-work rate cycle test

Secondary outcomes

  1. Functional exercise test 1

    Time frame: change from baseline to 12 weeks

    by means of a 6 minutes walk test

  2. Functional exercise test 2

    Time frame: change from baseline to 12 weeks

    by means of a 4 meter gait test

  3. Muscle function quadriceps

    Time frame: change from baseline to 12 weeks

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

  4. Respiratory muscle function

    Time frame: change from baseline to 12 weeks

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

  5. Muscle function hand grip

    Time frame: change from baseline to 12 weeks

    by means of measuring hand grip strength

  6. Muscle characteristics

    Time frame: change from baseline to 12 weeks

    Structural and metabolic parameters will be measured with dedicated methodology

  7. Blood parameters submaximal exercise test

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: change from baseline to 12 weeks

    by means of Charlson Morbidity index

  11. Comorbidities: ankle-brachial pressure index

    Time frame: change from baseline to 12 weeks

    by means of ankle-brachial pressure index

  12. Comorbidities blood pressure

    Time frame: change from baseline to 12 weeks

    by means of resting systolic and diastolic blood pressure

  13. Comorbidities body composition 1

    Time frame: change from baseline to 12 weeks

    by means of bio-electrical impedance

  14. Comorbidities body composition 2

    Time frame: change from baseline to 12 weeks

    by means of whole body dual X-ray absorptiometry

  15. Quality of life: anxiety and depression

    Time frame: change from baseline to 12 weeks

    by means of the "Hospital Anxiety and Depression Scale"

  16. Quality of life: fatigue

    Time frame: change from baseline to 12 weeks

    by means of the "Multidimensional Fatigue Inventory"

  17. Quality of life: dyspnea

    Time frame: change from baseline to 12 weeks

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

  18. Quality of life: general

    Time frame: change from baseline to 12 weeks

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

  19. Quality of life: COPD

    Time frame: change from baseline to 12 weeks

    by means of the "COPD assessment test"

  20. Physical activity: accelerometer

    Time frame: change from baseline to 12 weeks

    by means of physical activity monitoring via Actigraph (accelerometer)

  21. Physical activity: questionnaire 1

    Time frame: change from baseline to 12 weeks

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

  22. Physical activity: questionnaire 2

    Time frame: change from baseline to 12 weeks

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

  23. Lung function

    Time frame: change from baseline to 12 weeks

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

  24. Heart function

    Time frame: change from baseline to 12 weeks

    by means of resting ECG testing

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital

Registry information

Official study title

Oral β-Alanine Supplementation in Patients With COPD: Structural, Metabolic and Functional Adaptations

Acronym: BACOPD

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 12, 2016
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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