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

Primary Purpose

Chronic Obstructive Pulmonary Disease Patients

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Beta-glucan supplement group
Placebo group
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease Patients focused on measuring chronic obstructive pulmonary, beta-glucan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Beta-glucan supplement group

    Placebo group

    Arm Description

    Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg.

    Placebo capsule is empty capsule.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 18, 2023
    Last Updated
    May 26, 2023
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05878834
    Brief Title
    Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
    Official Title
    Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 25, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease Patients
    Keywords
    chronic obstructive pulmonary, beta-glucan

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Beta-glucan supplement group
    Arm Type
    Experimental
    Arm Description
    Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo capsule is empty capsule.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Beta-glucan supplement group
    Intervention Description
    Take 1 capsule 1 time per day for 12 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo group
    Intervention Description
    Take 1 capsule 1 time per day for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Forced expiratory volume in 1 second/Forced vital capacity
    Description
    Forced expiratory volume in 1 second/Forced vital capacity in % (high value means better pulmonary function)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Modified Medical Research Council Dyspnea Score
    Description
    Modified Medical Research Council Dyspnea Score shows in dyspnea score (score 0 to 4 means low dyspnea to high severity).
    Time Frame
    12 weeks
    Title
    Breathlessness, Cough, and Sputum Scale
    Description
    Breathlessness, Cough, and Sputum Scale shows in severity scale (scale 0 to 4 means no symptom to high severity)
    Time Frame
    12 weeks
    Title
    6-minute walk test
    Description
    6-minute walk test in walking distance in 6 minutes (meters) (high value means better performance)
    Time Frame
    12 weeks
    Title
    Chronic obstructive pulmonary disease assessment test
    Description
    Chronic obstructive pulmonary disease assessment test in scale 0 to 5 (high value means better quality of life)
    Time Frame
    12 weeks
    Title
    Tumor necrosis factor alpha
    Description
    Tumor necrosis factor alpha is a pro-inflammatory cytokine (picogram/ml) (high value means high risk of inflammation)
    Time Frame
    12 weeks
    Title
    Interleukin-6
    Description
    Interleukin-6 is a biomarker of inflammation (picogram/ml) (high value means high risk of inflammation)
    Time Frame
    12 weeks
    Title
    C-reactive protein
    Description
    C-reactive protein refers to inflammation (mg/ml) (high value means high risk of inflammation)
    Time Frame
    12 weeks
    Title
    Aspartate transaminase
    Description
    Aspartate transaminase refers to liver function (U/L)
    Time Frame
    12 weeks
    Title
    Alanine transaminase
    Description
    Alanine transaminase refers to liver function (U/L)
    Time Frame
    12 weeks
    Title
    Alkaline phosphatase
    Description
    Alkaline phosphatase refers to liver function (U/L)
    Time Frame
    12 weeks
    Title
    Creatinine
    Description
    Creatinine refers to renal function (mg/dl)
    Time Frame
    12 weeks
    Title
    Blood urea nitrogen
    Description
    Blood urea nitrogen refers to renal function (mg/dl)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pornanong Aramwit, Professor
    Phone
    +66899217255
    Email
    aramwit@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pornanong Aramwit, Professor
    Organizational Affiliation
    Chulalongkorn University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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