Clinical trial NCT02770417: Oral β-Alanine Supplementation in Patients With COPD
Official title: Oral β-Alanine Supplementation in Patients With COPD: Structural, Metabolic and Functional Adaptations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2016-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: muscle carnosine
timeFrame: change from baseline to 12 weeks
measure: maximal exercise capacity
timeFrame: change from baseline to 12 weeks
measure: submaximal exercise capacity
timeFrame: change from baseline to 12 weeks
Secondary outcomes:
measure: Functional exercise test 1
timeFrame: change from baseline to 12 weeks
measure: Functional exercise test 2
timeFrame: change from baseline to 12 weeks
measure: Muscle function quadriceps
timeFrame: change from baseline to 12 weeks
measure: Respiratory muscle function
timeFrame: change from baseline to 12 weeks
measure: Muscle function hand grip
timeFrame: change from baseline to 12 weeks
measure: Muscle characteristics
timeFrame: change from baseline to 12 weeks
measure: Blood parameters submaximal exercise test
timeFrame: change from baseline to 12 weeks
measure: Blood parameters fasted state
timeFrame: change from baseline to 12 weeks
measure: Blood parameters maximal exercise test
timeFrame: change from baseline to 12 weeks
measure: Comorbidities
timeFrame: change from baseline to 12 weeks
measure: Comorbidities: ankle-brachial pressure index
timeFrame: change from baseline to 12 weeks
measure: Comorbidities blood pressure
timeFrame: change from baseline to 12 weeks
measure: Comorbidities body composition 1
timeFrame: change from baseline to 12 weeks
measure: Comorbidities body composition 2
timeFrame: change from baseline to 12 weeks
measure: Quality of life: anxiety and depression
timeFrame: change from baseline to 12 weeks
measure: Quality of life: fatigue
timeFrame: change from baseline to 12 weeks
measure: Quality of life: dyspnea
timeFrame: change from baseline to 12 weeks
measure: Quality of life: general
timeFrame: change from baseline to 12 weeks
measure: Quality of life: COPD
timeFrame: change from baseline to 12 weeks
measure: Physical activity: accelerometer
timeFrame: change from baseline to 12 weeks
measure: Physical activity: questionnaire 1
timeFrame: change from baseline to 12 weeks
measure: Physical activity: questionnaire 2
timeFrame: change from baseline to 12 weeks
measure: Lung function
timeFrame: change from baseline to 12 weeks
measure: Heart function
timeFrame: change from baseline to 12 weeks
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis (ReGo)
Study officials:
affiliation: Hasselt University
name: Martijn Spruit, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Jana De Brandt, drs
role: STUDY_CHAIR
References:
citation: 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.