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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease Patients
• Intervention / Treatment: Dietary supplement: Beta-glucan supplement group; Dietary supplement: Placebo group

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pornanong Aramwit, Professor; Phone Number: +66899217255; Email: aramwit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Pornanong Aramwit, Professor, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: beta-glucan; chronic obstructive pulmonary
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Oh87/65

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No