Effect of Cordyceps Militaris Beverage on the Immune Response

NCT ID: NCT06138444

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2023-02-28

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Male received functional beverages

Male received single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM)

Group Type: EXPERIMENTAL

Functional beverages from the submerged fermentation of Cordyceps militaris

Intervention Type: DIETARY_SUPPLEMENT

The Cordyceps militaris submerged fermentation in fruit juice.

Male received placebo

Male received placebo

Group Type: PLACEBO_COMPARATOR

Fruit juice

Intervention Type: OTHER

Fruit juice is used as a placebo.

Female received functional beverages

Female received single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM)

Group Type: EXPERIMENTAL

Functional beverages from the submerged fermentation of Cordyceps militaris

Intervention Type: DIETARY_SUPPLEMENT

The Cordyceps militaris submerged fermentation in fruit juice.

Female received placebo

Female received placebo

Group Type: PLACEBO_COMPARATOR

Fruit juice

Intervention Type: OTHER

Fruit juice is used as a placebo.

Interventions

Functional beverages from the submerged fermentation of Cordyceps militaris

The Cordyceps militaris submerged fermentation in fruit juice.

Intervention Type: DIETARY_SUPPLEMENT

Fruit juice

Fruit juice is used as a placebo.

Intervention Type: OTHER

Other Intervention Names

FCM; Placebo

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Innovation Agency (NIA)

UNKNOWN

Sponsor Role: collaborator

University of Phayao

OTHER

Sponsor Role: lead

Responsible Party

Atcharaporn Ontawong

Assistant Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atcharaporn Ontawong, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Phayao

Locations

University Of Phayao

Nai Muang, Changwat Phayao, Thailand

Countries

Thailand

Other Identifiers

UP-HEC 1.3/026/65

Identifier Type: -

Identifier Source: org_study_id