Dose-escalation safety of novel fungal beta-glucans

Clinical trial for identification of safe dose of Beta- Glucan polysaccharide and Beta-Glucan oligosaccharide from Ophiocordyceps dipterigena BCC2073 in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240705004

Enrollment

Registered

2024-07-05

Start date

2023-01-03

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy adult individuals beta-Glucans Polysaccharides Oligosaccharides Fungi Clinical Trial Safety Dietary Supplements Dose-escalation study

Interventions

- single ascending dose phase: 2 mg and escalating to 50, 100, 300, 500, 700, 900, 1100, 1300, 1500, 1700, 1800, 1900, and 2000 mg - multiple ascending dose phase: 2 mg and escalating to 100, 500, 10

Experimental Dietary Supplement,Experimental Dietary Supplement

beta-glucans polysaccharide from Ophiocordyceps dipterigena BCC 2073,beta-glucans oligosaccharide from Ophiocordyceps dipterigena BCC 2073

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
symptoms related to the safety and tolerability of products at 2, 4, 6, 8, 10, 12 weeks subject diary and interview,blood biochemical parameters (liver, kidney function, CBC, lipid profile, fasting blood sugar) at 2, 4, 6, 8, 10, 12 weeks blood test,body weight at 2, 4, 6, 8, 10, 12 weeks weighing scale	—

Secondary

Measure	Time frame
dietary intake at 2, 4, 6, 8, 10, 12 weeks diet record	—

Countries

Thailand

Contacts

Public ContactDunyaporn Trachootham

Institute of Nutrition, Mahidol University

dunyaporn.tra@mahidol.edu66846953647

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026