Dose-escalation safety of novel fungal beta-glucans

Phase 1

Completed

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

• Registration Number: TCTR20240705004
• Lead Sponsor: Institute of Nutrition, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-06-29
• Study Start: 2024-07-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
dietary intake at 2, 4, 6, 8, 10, 12 weeks diet record