Evaluation of immune modulation by beta-glucan, a soluble dietary fiber derived from reishi mushroom in healthy adult volunteers, a systemic clinical trial

ISRCTN	ISRCTN48306294
DOI	https://doi.org/10.1186/ISRCTN48306294
Secondary identifying numbers	IRB00001145

Submission date: 25/10/2022
Registration date: 31/10/2022
Last edited: 20/04/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
To study how beta glucan, a soluble fiber isolated from an edible mushroom (Reishi, G. lucidum) can help fortify a healthy person's immune system.

Who can participate?
Healthy volunteers aged 18 to 55 years.

What does the study involve?
The study involves a simple, systemic regimen of taking the intervention/placebo dose (orally) once a day. Two blood drawn at the beginning and conclusion of the study.

What are the possible benefits and risks of participating?
Participants may feel more energetic and have a stronger resistance when stressed/under the weather. Risk may include minor allergic reaction if allergic to mushrooms, however, this should be excluded during the inclusion period.

Where is the study run from?
Super Beta Glucan Inc., Biomedical Research Division (USA)

When is the study starting and how long is it expected to run for?

Who is funding the study?
Super Beta Glucan Inc., Biomedical Research Division (USA)

Who is the main contact?
Dr Sherwin Chen, sherwinc@gmail.com

Contact information

Dr Sherwin Chen
Scientific

5 Holland, #109
Irvine
92618
United States of America

ORCID ID	0000-0001-8117-0738
Phone	+1-949-878-5801
Email	sherwinc@alumni.usc.edu

Study information

Study design	Randomized double-blinded placebo-controlled multicenter clinical study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	Randomized, placebo-controlled clinical study for the evalutation of immune modulation by Immulink MBG (Beta 1-3; 1-6 D-glucan; Poly-(l-6)-β-D-glucopyranosyl-(l,3)-β-D-glucopyranose) in healthy adult volunteers
Study objectives	To investigate the effect of orally administered Beta 1-3; 1-6 D-glucan derived from G. lucidum on various biomarkers and to explore the immunomodulatory mechanisms among a healthy adult population.
Ethics approval(s)	Approved 01/03/2019, Glytheron IRB (24552 Raymond Way, Unit 54, Lake Forest, CA 92609, United States; +1 949-878-5800; IRB@glytheron.org), ref: NTUH00000336/ IRB00001145
Health condition(s) or problem(s) studied	The effect of orally administered Beta 1-3; 1-6 D-glucan in healthy volunteers
Intervention	Subjects were randomly assigned, through randomly permuted blocks generated by a random number generator (SPSS software version 22), to either the intervention group (200 mg of beta glucan in a capsule) or a placebo group (200 mg of dextrose monohydrate in a capsule) upon enrollment. Subjects began taking the intervention or placebo at Day 0, week 1 following completing the first venous peripheral blood sample collection. Subjects were provided with 84 days of supply and were instructed to take the test article on SID basis. Dosing was 200 mg of placebo or intervention dose (1 capsule) per day for consecutive 84 days (12 weeks). Subjects were instructed to self-administer the allotted dose once daily in the morning before or while having breakfast, for the entire 84 days. An interim safety monitoring will take place from Day 43 to Day 45 via phone calls when deemed necessary by the DSMB. At the end of the test article administration period (day 84, week 12), venous peripheral blood samples were collected to analyze for the following parameters including Total lymphocytes, CD3+, CD4+, CD8+, Natural Killer (NK) cell counts, NK cell mediated cytotoxicity, IgA, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Red Blood Cell (RBC), Hemoglobin (HB), Hematocrit (HCT) and Platelet Counts.
Intervention type	Supplement
Primary outcome measure	Serum biomarkers including CD3+, CD4+, CD8+ T and NK cells counts, CD4/Cd8 Ratio, NK-cell cytotoxicity, immunoglobulin A (IgA) (Serum) using serum samples at baseline (Day 0, week 1) and Day 84, week 12
Secondary outcome measures	Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Red Blood Cell (RBC), Hemoglobin (HB), Hematocrit (HCT) and Platelet Counts using serum samples at baseline (Day 0, week 1) and Day 84, week 12
Overall study start date	30/03/2019
Completion date	08/01/2020

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	160
Total final enrolment	173
Key inclusion criteria	1. Male and female (unpregnant) subjects between 18 and 55 years of age, inclusive. 2. Participants willing to refrain from taking any non-essential medication from the onset of the study until follow up evaluation, with the exception of medical emergency.
Key exclusion criteria	1. Participant who was not able to give adequate informed consent; without the legal ability to act; who lack sufficient understanding or capacity to make or communicate responsible decisions. 2. Participants who were unable to adhere to the study protocols. 3. Participants participated in any other research study. 4. Participants who were current smoker or tobacco related product user. 5. Women who are pregnant or nursing. 6. Participants with status asthmaticus. 7. Participants with uncontrolled hypertension, peripheral vascular disease, hepatic diseases (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia. 8. Participants with evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. 9. Participants who have had organ transplantation(s), under treatments of immunosuppressant medications, diagnosed with cancer or any other malignancy, or type I/II diabetes mellitus. 10. Participants who have had any life threatening allergic event in the past. 11. Participants or have allergy events to dextrose monohydrate. 12. Participants taking medications, mainly glucocorticoids.
Date of first enrolment	30/03/2019
Date of final enrolment	29/08/2019

Locations

Countries of recruitment

Taiwan

Study participating centre

TYB Biomedical Research Center

No. 2, Ln. 315, Sec. 2
Zhongshan Rd.
Zhonghe Dist.
New Taipei City
235072
Taiwan

Sponsor information

Super Beta Glucan Inc., Biomedical Research Division
Research organisation

5 Holland, #109
Irvine
92618
United States of America

Phone	+1-949-878-5801
Email	RD@superbetaglucan.com

Funders

Funder type

Industry

Super Beta Glucan Inc., Biomedical Research Division

No information available

Results and Publications

Intention to publish date	02/01/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned publication in an SCI peer reviewed journal
IPD sharing plan	The datasets generated and/or analyzed during the current study will be published as a supplement to the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		03/02/2023	20/04/2023	Yes	No

Editorial Notes

20/04/2023: Publication reference added.
31/10/2022: Trial's existence confirmed by Super Beta Glucan