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Completed

NCT Number: NCT06138444

Effect of Cordyceps Militaris Beverage on the Immune Response

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.

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Key information

Conditions

Healthy

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Phayao

Nai Muang, Changwat Phayao, 56000, Thailand

About this study

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

  • 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional beverages from the submerged fermentation of Cordyceps militaris

Dietary Supplement

The Cordyceps militaris submerged fermentation in fruit juice.

Other names: FCM

Fruit juice

Other

Fruit juice is used as a placebo.

Other names: Placebo

Primary outcomes

  1. Change from the baseline on physical examination (Height)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for height (Centimeter).

  2. Change from the baseline on the physical examination (Weight)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for weight (Kilogram).

  3. Change from the baseline on the physical examination (Blood pressure)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for blood pressure using an automatic blood pressure monitor (mmHg).

  4. Change from the baseline on the physical examination (oxygen saturation)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for oxygen saturation using a fingertip pulse oximeter (%).

  5. Change from the baseline on the physical examination (adverse reactions)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    The first visit was conducted within one week after screening. Every 15 days after taking the test substance, the subjects were examined for adverse reactions (Questionnaire).

  6. Change from the baseline on the immune response (NK cells)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in natural killer cells (NK cells), measurement by using flow cytometry-based assays.

  7. Change from the baseline on the cluster of differentiation (CD) antigens

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.

    This experiment examined the changes in cluster of differentiation (CD) antigens

    • Cluster of differentiation 3 (CD3)
    • Cluster of differentiation 4 (CD4)
    • Cluster of differentiation 8 (CD8)
    • B-lymphocyte antigen CD19 (CD19)

    Measurement by using flow cytometry-based assays.

  8. Change from the baseline on the immunoglobulins

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.

    This experiment examined the changes in immunoglobulins

    • Immunoglobulin A (IgA)
    • Immunoglobulin G (IgG)
    • Immunoglobulin M (IgM)

    Measurement by using flow cytometry-based assays.

  9. Change from the baseline on the inflammatory cytokines

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.

    This experiment examined the changes in inflammatory markers

    • Tumor necrosis factor alpha (TNF-α)
    • Interleukin 1 beta (IL-1β)
    • Interleukin 6 (IL-6)

    Measurement by using ELISA assay.

  10. Change from the baseline on the safety parameters (Complete blood count (CBC))

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in complete blood count (CBC), measurement by using colorimetric assays.

  11. Change from the baseline on the safety parameters (Fasting blood glucose)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection. This experiment examined the changes in fasting blood glucose, measurement by using colorimetric assays.

  12. Change from the baseline on the safety parameters (Plasma lipids)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.

    This experiment examined the changes in safety parameters

    • Triglyceride
    • Total cholesterol

    Measurement by using colorimetric assays.

  13. Change from the baseline on the safety parameters (Renal function)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.

    This experiment examined the changes in safety parameters

    • Creatinine
    • Total protein

    Measurement by using colorimetric assays.

  14. Change from the baseline on the safety parameters (Liver function)

    Time frame: At 0, 4 and 8 weeks after end of the intervention

    Blood samples (10 ml for each time point) were collected at 0, 30, and 60 days. The fasting blood samples were collected into plain and ethylenediamine tetraacetic acid (EDTA) tubes and delivered to the laboratory within 2 hours of collection.

    This experiment examined the changes in safety parameters

    • Aspartate aminotransferase (AST)
    • Alanine aminotransferase (ALT)

    Measurement by using colorimetric assays.

Sponsors and collaborators

Lead sponsor

University of Phayao

Other

Collaborators

  • National Innovation Agency (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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