A Randomized Controlled Clinical Trial of Cordyceps militaris Beverage on the Immune Response

Completed

• Conditions: Male and female healthy subjects; Cordyceps militaris, Healthy subjects, NK cell, Cytokine, Immunomodulation

• Registration Number: TCTR20231003001
• Lead Sponsor: ational Innovation Agency (NIA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-02-10
• Study Start: 2023-10-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1) Male and female adult participants aged 25-60 during the screening test.
2) No history of hypersensitivity or idiosyncratic reactions to drugs or herbal products.
3) Willing to participate in the project throughout the research program.

Exclusion Criteria

1) Participants diagnosed with immune-mediated disease, nervous system disorders, cardiovascular disease, or liver or kidney disease.
2) Participants diagnosed with chronic health problems such as hypertension, diabetes, or renal failure, etc.
3) A body mass index (BMI) greater than 29.9 or less than 18 kg/m2.
4) Participants who were pregnant or lactating or intended to become pregnant during the trial period.
5) Participants who, within two weeks, ingested a drug or functional food that may affect the immunomodulatory effect of the test product
6) Participants who had an alanine transaminase (ALT) or aspartate transaminase (AST) plasma level more than three times the guideline of the organization.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune Response at 4 and 8 weeks after end of the intervention T cell absolute count, B cell absolute count, Natural Killer (NK) cell absolute count, and Cytokine levels

Secondary Outcome Measures

Name	Time	Method
Safety at 4 and 8 weeks after end of the intervention Hematological, metabolic, and safety indexes