Safety for Continnuous Intake of fungal Beta-Glucan polysaccharide and Beta-Glucan oligosaccharide in healthy volunteers

Phase 1

Completed

• Conditions: healthy participants; beta-Glucans; Polysaccharides; Oligosaccharides; Fungi; Randomized Controlled Trial; Safety; Dietary Supplements

• Registration Number: TCTR20240622005
• Lead Sponsor: Institute of Nutrition, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-05-30
• Study Start: 2024-06-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. 20-55 years old, 2. healthy with no systemic diseases, 3. BMI less than 30 kg/m2, 4. acceptable normal blood biochemical parameters (hemoglobin 11-16 gm/ dL for female or 12-18 gm/dL for male, white blood cells 4,000 to 10,000 cells/mm3, asting plasma glucose no more than 125 mg/dL, HbA1c no more than 5.8 percent, total cholesterol/ HDL ratio no more than 5.1, ALT no more than 60 U/L, eGFR at least 90 mL/min/ 1.73 m2), 5. acceptable normal blood pressure (diastolic pressure 60-90 mm Hg, systolic pressure 90-140 mm Hg), 6. normal heart rate (no more than 100 times/ min)

Exclusion Criteria

1.History of COVID-19 infection or exposure, 2. History of allergy to Cordyceps or other herbs, 3. Unable to follow-up every 4 weeks, 4. Pregnant or plan to get pregnant within 3 months, 5. Regular consumption of drugs, herbs or dietary supplements, 6. Breastfeeding, 7. alcohol intake > 14 drinks per week for male or > 7 drinks per week for females and cannot refrain from alcohol intake during the study, 8. smoking > 10 cigarettes/day, 9. Bleeding problems e.g. idiopathic thrombocytopenia, 10. Having certain conditions not suitable to consume beta-glucans e.g. severe gastrointestinal 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 4, 8, 12, 14 weeks after intervention subject diary and interview,blood biochemical parameters (liver, kidney function, CBC, lipid profile, fasting blood sugar) 4, 8, 12, 14 weeks after intervention blood test ,body weight 4, 8, 12, 14 weeks after intervention weighing scale,urine parameters (color, pH, protein, WBC, RBC, bacteria, etc) 4, 8, 12, 14 weeks after intervention urinalysis,EKG 4, 8, 12, 14 weeks after intervention EKG

Secondary Outcome Measures

Name	Time	Method
defecation frequency weekly subject diary ,stool consistency weekly Bristol stool scale