Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
- Conditions
- Chronic Obstructive Pulmonary Disease Patients
- Interventions
- Dietary Supplement: Placebo groupDietary Supplement: Beta-glucan supplement group
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
- Arm && Interventions
Group Intervention Description Placebo group Placebo group Placebo capsule is empty capsule. Beta-glucan supplement group Beta-glucan supplement group Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg.
- 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)