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

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease Patients

• Registration Number: NCT05878834
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-18
• Study Start: 2023-05-25
• Study First Posted: 2023-05-26
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1 second/Forced vital capacity	12 weeks	Forced expiratory volume in 1 second/Forced vital capacity in % (high value means better pulmonary function)

Secondary Outcome Measures

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