Oral β-Alanine Supplementation in Patients With COPD

NCT02770417 | Completed

• 1 other identifier: BACOPD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (3)

• muscle carnosine

  by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy

  change from baseline to 12 weeks

• maximal exercise capacity

  by means of an incremental maximal cycle test

  change from baseline to 12 weeks

• submaximal exercise capacity

  by means of a constant-work rate cycle test

  change from baseline to 12 weeks

Secondary Outcomes (24)

• Functional exercise test 1

  change from baseline to 12 weeks

• Functional exercise test 2

  change from baseline to 12 weeks

• Muscle function quadriceps

  change from baseline to 12 weeks

• Respiratory muscle function

  change from baseline to 12 weeks

• Muscle function hand grip

  change from baseline to 12 weeks

Study Arms (3)

COPD (beta-alanine)

ACTIVE COMPARATOR

Dietary Supplement: beta-alanine

COPD (placebo)

PLACEBO COMPARATOR

Dietary Supplement: placebo

Healthy controls

OTHER

Other: control

Interventions

beta-alanine DIETARY_SUPPLEMENT

Patients receive beta-alanine

COPD (beta-alanine)

placebo DIETARY_SUPPLEMENT

Patients receive placebo

COPD (placebo)

control OTHER

Healthy controls will be assessed to compare baseline muscle carnosine levels

Healthy controls

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 exacerbation and/or hospitalization in the last 6 weeks
• participation in pulmonary rehabilitation in the previous 12 months.

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis (ReGo)

Hasselt, 3500, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35977911 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

beta-Alanine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alanine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Martijn Spruit, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Jana De Brandt, drs

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 12, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

BE (1)