Oral ß-Alanine Supplementation in Patients With COPD

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02770417
• Date of registration: 09/05/2016
• Prospective Registration: No
• Primary sponsor: Hasselt University
• Public title: Oral ß-Alanine Supplementation in Patients With COPD BACOPD
• Scientific title: Oral ß-Alanine Supplementation in Patients With COPD: Structural, Metabolic and Functional Adaptations
• Date of first enrolment: May 2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02770417
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Martijn Spruit, prof. dr.
• Affiliation: Hasselt University

• Name: Jana De Brandt, drs
• Affiliation: Hasselt University

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Intervention(s)

Dietary Supplement: placebo

Other: control

Dietary Supplement: beta-alanine

Primary Outcome(s)

muscle carnosine [Time Frame: change from baseline to 12 weeks]

maximal exercise capacity [Time Frame: change from baseline to 12 weeks]

submaximal exercise capacity [Time Frame: change from baseline to 12 weeks]

Secondary Outcome(s)

Blood parameters maximal exercise test [Time Frame: change from baseline to 12 weeks]

Lung function [Time Frame: change from baseline to 12 weeks]

Blood parameters submaximal exercise test [Time Frame: change from baseline to 12 weeks]

Muscle characteristics [Time Frame: change from baseline to 12 weeks]

Comorbidities [Time Frame: change from baseline to 12 weeks]

Comorbidities blood pressure [Time Frame: change from baseline to 12 weeks]

Comorbidities body composition 2 [Time Frame: change from baseline to 12 weeks]

Muscle function quadriceps [Time Frame: change from baseline to 12 weeks]

Blood parameters fasted state [Time Frame: change from baseline to 12 weeks]

Comorbidities body composition 1 [Time Frame: change from baseline to 12 weeks]

Functional exercise test 1 [Time Frame: change from baseline to 12 weeks]

Physical activity: questionnaire 2 [Time Frame: change from baseline to 12 weeks]

Quality of life: COPD [Time Frame: change from baseline to 12 weeks]

Quality of life: general [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]

Physical activity: accelerometer [Time Frame: change from baseline to 12 weeks]

Comorbidities: ankle-brachial pressure index [Time Frame: change from baseline to 12 weeks]

Functional exercise test 2 [Time Frame: change from baseline to 12 weeks]

Heart function [Time Frame: change from baseline to 12 weeks]

Physical activity: questionnaire 1 [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: dyspnea [Time Frame: change from baseline to 12 weeks]

Quality of life: fatigue [Time Frame: change from baseline to 12 weeks]

Secondary ID(s)

BACOPD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jessa Hospital