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

Not Applicable

Completed

• Conditions: The effect of orally administered Beta 1-3; 1-6 D-glucan in healthy volunteers; Not Applicable

• Registration Number: ISRCTN48306294
• Lead Sponsor: Super Beta Glucan Inc., Biomedical Research Division

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36766186/ (added 20/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-08
• Study Start: 2022-10-31
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 173

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified