Oral β-Alanine Supplementation in Patients With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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COPD (beta-alanine)

Group Type ACTIVE_COMPARATOR

beta-alanine

Intervention Type DIETARY_SUPPLEMENT

Patients receive beta-alanine

COPD (placebo)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Patients receive placebo

Healthy controls

Group Type OTHER

control

Intervention Type OTHER

Healthy controls will be assessed to compare baseline muscle carnosine levels

Interventions

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beta-alanine

Patients receive beta-alanine

Intervention Type DIETARY_SUPPLEMENT

placebo

Patients receive placebo

Intervention Type DIETARY_SUPPLEMENT

control

Healthy controls will be assessed to compare baseline muscle carnosine levels

Intervention Type OTHER

Eligibility Criteria

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes