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

Chronic Obstructive Pulmonary Disease Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05878834
• Other study ID #: Oh87/65
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: May 2023
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Professor
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 20, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Patients
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Beta-glucan supplement group
Take 1 capsule 1 time per day for 12 weeks.
• Placebo group
Take 1 capsule 1 time per day for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	6-minute walk test	6-minute walk test in walking distance in 6 minutes (meters) (high value means better performance)	12 weeks
Secondary	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
Secondary	Tumor necrosis factor alpha	Tumor necrosis factor alpha is a pro-inflammatory cytokine (picogram/ml) (high value means high risk of inflammation)	12 weeks
Secondary	Interleukin-6	Interleukin-6 is a biomarker of inflammation (picogram/ml) (high value means high risk of inflammation)	12 weeks
Secondary	C-reactive protein	C-reactive protein refers to inflammation (mg/ml) (high value means high risk of inflammation)	12 weeks
Secondary	Aspartate transaminase	Aspartate transaminase refers to liver function (U/L)	12 weeks
Secondary	Alanine transaminase	Alanine transaminase refers to liver function (U/L)	12 weeks
Secondary	Alkaline phosphatase	Alkaline phosphatase refers to liver function (U/L)	12 weeks
Secondary	Creatinine	Creatinine refers to renal function (mg/dl)	12 weeks
Secondary	Blood urea nitrogen	Blood urea nitrogen refers to renal function (mg/dl)	12 weeks