Chronic Obstructive Pulmonary Disease (COPD)BACOPDNCT02770417
Oral β-Alanine Supplementation in Patients With COPD
A study testing beta-alanine in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- beta-alanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- May 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral β-Alanine Supplementation in Patients With COPD: Structural, Metabolic and Functional Adaptations
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:
- Investigate baseline muscle carnosine levels to confirm the pilot data in a larger sample of patients with COPD compared with healthy elderly subjects
- 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
- 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
- Being tested
- beta-alanine, placebo, control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-alanineDietary supplement
Patients receive beta-alanine
placeboDietary supplement
Patients receive placebo
controlOther
Healthy controls will be assessed to compare baseline muscle carnosine levels
| Study group | Role | What they receive |
|---|---|---|
| COPD (beta-alanine) | Active comparator | Not described Receives: Dietary Supplement: beta-alanine |
| COPD (placebo) | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
| Healthy controls | Other | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle carnosine
by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy
Measured: change from baseline to 12 weeks
maximal exercise capacity
by means of an incremental maximal cycle test
Measured: change from baseline to 12 weeks
submaximal exercise capacity
by means of a constant-work rate cycle test
Measured: change from baseline to 12 weeks
Secondary outcomes (24)
Functional exercise test 1
by means of a 6 minutes walk test
Measured: change from baseline to 12 weeks
Functional exercise test 2
by means of a 4 meter gait test
Measured: change from baseline to 12 weeks
Muscle function quadriceps
by means of measuring quadriceps (isometric and isokinetic knee extension-flexion)
Measured: change from baseline to 12 weeks
Respiratory muscle function
by means of measuring respiratory muscle strength (maximal inspiratory and expiratory pressure)
Measured: change from baseline to 12 weeks
Muscle function hand grip
by means of measuring hand grip strength
Measured: change from baseline to 12 weeks
Muscle characteristics
Structural and metabolic parameters will be measured with dedicated methodology
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline to 12 weeks
Comorbidities
by means of Charlson Morbidity index
Measured: change from baseline to 12 weeks
Comorbidities: ankle-brachial pressure index
by means of ankle-brachial pressure index
Measured: change from baseline to 12 weeks
Comorbidities blood pressure
by means of resting systolic and diastolic blood pressure
Measured: change from baseline to 12 weeks
Comorbidities body composition 1
by means of bio-electrical impedance
Measured: change from baseline to 12 weeks
Comorbidities body composition 2
by means of whole body dual X-ray absorptiometry
Measured: change from baseline to 12 weeks
Quality of life: anxiety and depression
by means of the "Hospital Anxiety and Depression Scale"
Measured: change from baseline to 12 weeks
Quality of life: fatigue
by means of the "Multidimensional Fatigue Inventory"
Measured: change from baseline to 12 weeks
Quality of life: dyspnea
by means of the " Modified Medical Research Council (MMRC) dyspnea grade"
Measured: change from baseline to 12 weeks
Quality of life: general
by means of the "Euroqol 5 dimensions (EQ-5D) generic questionnaire"
Measured: change from baseline to 12 weeks
Quality of life: COPD
by means of the "COPD assessment test"
Measured: change from baseline to 12 weeks
Physical activity: accelerometer
by means of physical activity monitoring via Actigraph (accelerometer)
Measured: change from baseline to 12 weeks
Physical activity: questionnaire 1
by means of physical activity monitoring via "Behavioural Regulation in Exercise Questionnaire"
Measured: change from baseline to 12 weeks
Physical activity: questionnaire 2
by means of physical activity monitoring via "Modified Baecke questionnaire"
Measured: change from baseline to 12 weeks
Lung function
by means of general pulmonary function (spirometry, long volumes, diffusion capacity for carbon monoxide).
Measured: change from baseline to 12 weeks
Heart function
by means of resting ECG testing
Measured: change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Martijn Spruit, Hasselt University
- Investigators
- Martijn Spruit, prof. dr., Principal investigator, Hasselt UniversityJana De Brandt, drs, Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770417
- Sponsor's protocol ID
- BACOPD
- Acronym
- BACOPD
- Status last verified
- Feb 2019
- First submitted
- 9 May 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35977911
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral β-Alanine Supplementation in Patients With COPD: Structural, Metabolic and Functional Adaptations
- ClinicalTrials.gov ID
- NCT02770417
- Acronym / sponsor ID
- BACOPD / BACOPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Investigate baseline muscle carnosine levels to confirm the pilot data in a larger sample of patients with COPD compared with healthy elderly subjects
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD (beta-alanine) | Active comparator | Dietary Supplement: beta-alanine |
| COPD (placebo) | Placebo comparator | Dietary Supplement: placebo |
| Healthy controls | Other | Other: control |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beta-alaninePatients receive beta-alanine | Dietary supplement | COPD (beta-alanine) |
| placeboPatients receive placebo | Dietary supplement | COPD (placebo) |
| controlHealthy controls will be assessed to compare baseline muscle carnosine levels | Other | Healthy controls |
Primary outcome
muscle carnosine
Time frame: change from baseline to 12 weeks
by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy
maximal exercise capacity
Time frame: change from baseline to 12 weeks
by means of an incremental maximal cycle test
submaximal exercise capacity
Time frame: change from baseline to 12 weeks
by means of a constant-work rate cycle test
24 secondary outcomes
Functional exercise test 1
Time frame: change from baseline to 12 weeks
Functional exercise test 2
Time frame: change from baseline to 12 weeks
Muscle function quadriceps
Time frame: change from baseline to 12 weeks
Respiratory muscle function
Time frame: change from baseline to 12 weeks
Muscle function hand grip
Time frame: change from baseline to 12 weeks
Muscle characteristics
Time frame: change from baseline to 12 weeks
Blood parameters submaximal exercise test
Time frame: change from baseline to 12 weeks
Blood parameters fasted state
Time frame: change from baseline to 12 weeks
Blood parameters maximal exercise test
Time frame: change from baseline to 12 weeks
Comorbidities
Time frame: change from baseline to 12 weeks
Comorbidities: ankle-brachial pressure index
Time frame: change from baseline to 12 weeks
Comorbidities blood pressure
Time frame: change from baseline to 12 weeks
Comorbidities body composition 1
Time frame: change from baseline to 12 weeks
Comorbidities body composition 2
Time frame: change from baseline to 12 weeks
Quality of life: anxiety and depression
Time frame: change from baseline to 12 weeks
Quality of life: fatigue
Time frame: change from baseline to 12 weeks
Quality of life: dyspnea
Time frame: change from baseline to 12 weeks
Quality of life: general
Time frame: change from baseline to 12 weeks
Quality of life: COPD
Time frame: change from baseline to 12 weeks
Physical activity: accelerometer
Time frame: change from baseline to 12 weeks
Physical activity: questionnaire 1
Time frame: change from baseline to 12 weeks
Physical activity: questionnaire 2
Time frame: change from baseline to 12 weeks
Lung function
Time frame: change from baseline to 12 weeks
Heart function
Time frame: change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 35977911De 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn Spruit, prof. dr. principal investigator
Hasselt University
Jana De Brandt, drs study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beta-alanine in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle carnosine (time frame: change from baseline to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.