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Oral β-Alanine Supplementation in Patients With COPD (BACOPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02770417
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
Martijn Spruit, 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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Dietary Supplement: beta-alanine Dietary Supplement: placebo Other: control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral β-Alanine Supplementation in Patients With COPD: Structural, Metabolic and Functional Adaptations
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Alanine

Arm Intervention/treatment
Active Comparator: COPD (beta-alanine) Dietary Supplement: beta-alanine
Patients receive beta-alanine

Placebo Comparator: COPD (placebo) Dietary Supplement: placebo
Patients receive placebo

Healthy controls Other: control
Healthy controls will be assessed to compare baseline muscle carnosine levels




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770417


Locations
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Belgium
Jessa Ziekenhuis (ReGo)
Hasselt, Belgium, 3500
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Principal Investigator: Martijn Spruit, prof. dr. Hasselt University
Study Chair: Jana De Brandt, drs Hasselt University
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Responsible Party: Martijn Spruit, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02770417    
Other Study ID Numbers: BACOPD
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases