Clinical trial NCT06138444: Effect of Cordyceps Militaris Beverage on the Immune Response
Official title: A Randomized Controlled Clinical Trial of Cordyceps Militaris Beverage on the Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Cordyceps militaris
Healthy subjects
NK cell
Cytokine
Immunomodulation
Lead sponsor: University of Phayao
Sponsor class: OTHER
Collaborators: name: National Innovation Agency (NIA)
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Male or female received a single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) or placebo.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from the baseline on physical examination (Height)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the physical examination (Weight)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the physical examination (Blood pressure)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the physical examination (oxygen saturation)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the physical examination (adverse reactions)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the immune response (NK cells)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the cluster of differentiation (CD) antigens
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the immunoglobulins
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the inflammatory cytokines
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the safety parameters (Complete blood count (CBC))
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the safety parameters (Fasting blood glucose)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the safety parameters (Plasma lipids)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the safety parameters (Renal function)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
measure: Change from the baseline on the safety parameters (Liver function)
timeFrame: At 0, 4 and 8 weeks after end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Nai Muang
country: Thailand
facility: University Of Phayao
state: Phayao
Study officials:
affiliation: University of Phayao
name: Atcharaporn Ontawong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: