The effect of orally administered Beta 1-3
Conditions
Interventions
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 capsul
Sponsors
Super Beta Glucan Inc., Biomedical Research Division
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Taiwan
Outcome results
None listed