Oral β-Alanine Supplementation in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— BACOPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770417
• Other study ID #: BACOPD
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: February 2019

Study information

• Verified date: February 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• beta-alanine
Patients receive beta-alanine
• placebo
Patients receive placebo

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

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis (ReGo)	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle carnosine	by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy	change from baseline to 12 weeks
Primary	maximal exercise capacity	by means of an incremental maximal cycle test	change from baseline to 12 weeks
Primary	submaximal exercise capacity	by means of a constant-work rate cycle test	change from baseline to 12 weeks
Secondary	Functional exercise test 1	by means of a 6 minutes walk test	change from baseline to 12 weeks
Secondary	Functional exercise test 2	by means of a 4 meter gait test	change from baseline to 12 weeks
Secondary	Muscle function quadriceps	by means of measuring quadriceps (isometric and isokinetic knee extension-flexion)	change from baseline to 12 weeks
Secondary	Respiratory muscle function	by means of measuring respiratory muscle strength (maximal inspiratory and expiratory pressure)	change from baseline to 12 weeks
Secondary	Muscle function hand grip	by means of measuring hand grip strength	change from baseline to 12 weeks
Secondary	Muscle characteristics	Structural and metabolic parameters will be measured with dedicated methodology	change from baseline to 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Comorbidities	by means of Charlson Morbidity index	change from baseline to 12 weeks
Secondary	Comorbidities: ankle-brachial pressure index	by means of ankle-brachial pressure index	change from baseline to 12 weeks
Secondary	Comorbidities blood pressure	by means of resting systolic and diastolic blood pressure	change from baseline to 12 weeks
Secondary	Comorbidities body composition 1	by means of bio-electrical impedance	change from baseline to 12 weeks
Secondary	Comorbidities body composition 2	by means of whole body dual X-ray absorptiometry	change from baseline to 12 weeks
Secondary	Quality of life: anxiety and depression	by means of the "Hospital Anxiety and Depression Scale"	change from baseline to 12 weeks
Secondary	Quality of life: fatigue	by means of the "Multidimensional Fatigue Inventory"	change from baseline to 12 weeks
Secondary	Quality of life: dyspnea	by means of the " Modified Medical Research Council (MMRC) dyspnea grade"	change from baseline to 12 weeks
Secondary	Quality of life: general	by means of the "Euroqol 5 dimensions (EQ-5D) generic questionnaire"	change from baseline to 12 weeks
Secondary	Quality of life: COPD	by means of the "COPD assessment test"	change from baseline to 12 weeks
Secondary	Physical activity: accelerometer	by means of physical activity monitoring via Actigraph (accelerometer)	change from baseline to 12 weeks
Secondary	Physical activity: questionnaire 1	by means of physical activity monitoring via "Behavioural Regulation in Exercise Questionnaire"	change from baseline to 12 weeks
Secondary	Physical activity: questionnaire 2	by means of physical activity monitoring via "Modified Baecke questionnaire"	change from baseline to 12 weeks
Secondary	Lung function	by means of general pulmonary function (spirometry, long volumes, diffusion capacity for carbon monoxide).	change from baseline to 12 weeks
Secondary	Heart function	by means of resting ECG testing	change from baseline to 12 weeks