Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients

Study Overview
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Brief Summary
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The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.

Detailed Description
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There are 72 patients in this study. They are randomly divided into 2 groups which are beta-glucan supplement group and placebo group. The supplement will be taken 1 capsule/day for 12 weeks. Forced expiratory volume in 1 second/Forced vital capacity, Modified Medical Research Council Dyspnea Score, Breathlessness, Cough, and Sputum Scale, 6 Minute Walk Test, Diffusing capacity for carbon monoxide, Tumor necrosis factor alpha, Interleukin-6, C-reactive protein, glutathione, aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine, and blood urea nitrogen are assessed before and after taking supplement 6 and 12 weeks.

Official Title
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Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients

Conditions
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Chronic Obstructive Pulmonary Disease Patients

Intervention / Treatment
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* Dietary Supplement: Beta-glucan supplement group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 18 years Chronic Obstructive Pulmonary Disease with Forced expiratory volume in 1 second/Forced vital capacity after receiving bronchodilator medicine more than 70% No exacerbation and uncontrolled disease 10 pack-years smoking history 10 pack-years but stop smoking more than 1 years Willing to participate in this study Exclusion Criteria: Respiratory infection in 4 weeks Lung cancer Liver disease or kidney disease Lung surgery history Take kung supplement in 2 weeks Take warfarin, clopidogrel, aspirin, or digoxin Allergic to beta-glucan, broccoli, or quercetin Cannot use Spirometry Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta-glucan supplement group<br>Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg. | Dietary Supplement: Beta-glucan supplement group<br>* Take 1 capsule 1 time per day for 12 weeks.<br>|
| Placebo Comparator: Placebo group<br>Placebo capsule is empty capsule. | Dietary Supplement: Placebo group<br>* Take 1 capsule 1 time per day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second/Forced vital capacity | Forced expiratory volume in 1 second/Forced vital capacity in % (high value means better pulmonary function) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Medical Research Council Dyspnea Score | Modified Medical Research Council Dyspnea Score shows in dyspnea score (score 0 to 4 means low dyspnea to high severity). | 12 weeks | 
| Breathlessness, Cough, and Sputum Scale | Breathlessness, Cough, and Sputum Scale shows in severity scale (scale 0 to 4 means no symptom to high severity) | 12 weeks | 
| 6-minute walk test | 6-minute walk test in walking distance in 6 minutes (meters) (high value means better performance) | 12 weeks | 
| Chronic obstructive pulmonary disease assessment test | Chronic obstructive pulmonary disease assessment test in scale 0 to 5 (high value means better quality of life) | 12 weeks | 
| Tumor necrosis factor alpha | Tumor necrosis factor alpha is a pro-inflammatory cytokine (picogram/ml) (high value means high risk of inflammation) | 12 weeks | 
| Interleukin-6 | Interleukin-6 is a biomarker of inflammation (picogram/ml) (high value means high risk of inflammation) | 12 weeks | 
| C-reactive protein | C-reactive protein refers to inflammation (mg/ml) (high value means high risk of inflammation) | 12 weeks | 
| Aspartate transaminase | Aspartate transaminase refers to liver function (U/L) | 12 weeks | 
| Alanine transaminase | Alanine transaminase refers to liver function (U/L) | 12 weeks | 
| Alkaline phosphatase | Alkaline phosphatase refers to liver function (U/L) | 12 weeks | 
| Creatinine | Creatinine refers to renal function (mg/dl) | 12 weeks | 
| Blood urea nitrogen | Blood urea nitrogen refers to renal function (mg/dl) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary, beta-glucan