NCT06138444

Effect of Cordyceps Militaris Beverage on the Immune Response

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Phayao · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study developed functional beverages from the submerged fermentation of Cordyceps militaris (FCM) and aimed to investigate the potential of FCM in male and female healthy volunteers in Phayao province, Thailand. To provide essential information for the development of healthy drink products.

Detailed description

Healthy Thai males and females aged 25-60 were recruited at the School of Medical Sciences, University of Phayao, in 2022. Written informed consent was obtained from all research participants. A total of 40 participants were randomly assigned to one of the study groups (10 subjects each). 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. Laboratory research has been conducted to confirm the eligibility of research participants, including hematology, serum biochemistry, blood coagulation, and urinalysis. The participants who met the inclusion requirements were randomized into experimental groups. Twenty random numbers were generated using Statistical Package for the Social Sciences (SPSS) 26.0. Digits 1st-10th of each gender were numbered as the FCM group, and the remaining digits, 11th-20th of each gender, were numbered as the placebo group. All researchers, participants, and related medical staff were blinded to the intervention assignments throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Functional beverages from the submerged fermentation of Cordyceps militaris	The Cordyceps militaris submerged fermentation in fruit juice.
OTHER	Fruit juice	Fruit juice is used as a placebo.

Timeline

• Start date: 2022-11-22
• Primary completion: 2023-02-10
• Completion: 2023-02-28
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: Thailand