Effect of Cordyceps Militaris Beverage on the Immune Response
Condition: Healthy
Study type: Interventional

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.
    

Intervention name(s): Functional beverages from the submerged fermentation of Cordyceps militaris; Fruit juice
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The Cordyceps militaris submerged fermentation in fruit juice.; Fruit juice is used as a placebo.
Other intervention name(s): FCM; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Male or female received a single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cordyceps militaris; Healthy subjects; NK cell; Cytokine; Immunomodulation