TCTR20240705004
Completed
Phase 1
Clinical trial for identification of safe dose of Beta- Glucan polysaccharide and Beta-Glucan oligosaccharide from Ophiocordyceps dipterigena BCC2073 in healthy volunteers
Institute of Nutrition, Mahidol University0 sites18 target enrollmentJuly 5, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- healthy adult individuals
- Sponsor
- Institute of Nutrition, Mahidol University
- Enrollment
- 18
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy people aged more than 18 years old, 2\. Body mass index less than 30 kg/m2, 3\. No systematic diseases e.g. DM, obesity, liver disease, kidney diseases, thyroid disease, cancer, and autoimmune diseases, 4\. Normal vital signs, 5\. Normal blood biochemical parameters (Complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin blood urea nitrogen (BUN), creatinine, and fasting plasma glucose (FPG), 6\. Castelli risk index\-I (Total cholesterol (TC)/ high\-density lipoprotein cholesterol; (HDL\-C) not more than 5\.0 in men or 4\.5 in women
Exclusion Criteria
- •1\. Coagulation problems e.g. hemophilia, idiopathic thrombocytopenia, leukemia, taking anti\-coagulants e.g. warfarin, 2\. Pregnant or plan to be pregnant, 3\. Breastfeeding, 4\. Alcohol intake \> 14 drinks per week for male or \> 7 drinks per week for females and cannot refrain from alcohol intake during the study, 5\. Smoking \> 10 cigarettes/day, 6\. Allergy to coffee or caffeine, 7\. Anemia (Hematocrit \< 40% in males, \< 36% in female or Hemoglobin \< 13 g/DL in males, 12\< g/DL in females), 8\. In critical condition, 9\. Having infectious diseases.
Outcomes
Primary Outcomes
Not specified
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