Effect of Cordyceps Militaris Beverage on the Immune Response

NCT06138444 | Completed

• 1 other identifier: UP-HEC 1.3/026/65
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cordyceps militaris; Healthy subjects; NK cell; Cytokine; Immunomodulation

Outcome Measures

Primary Outcomes (14)

• Change from the baseline on physical examination (Height)

  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).

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

• Change from the baseline on the physical examination (Weight)

  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).

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

• Change from the baseline on the physical examination (Blood pressure)

  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).

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

• Change from the baseline on the physical examination (oxygen saturation)

  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 (%).

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

• Change from the baseline on the physical examination (adverse reactions)

  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).

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

• Change from the baseline on the immune response (NK cells)

  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.

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

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

  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 1. Cluster of differentiation 3 (CD3) 2. Cluster of differentiation 4 (CD4) 3. Cluster of differentiation 8 (CD8) 4. B-lymphocyte antigen CD19 (CD19) Measurement by using flow cytometry-based assays.

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

• Change from the baseline on the immunoglobulins

  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 1. Immunoglobulin A (IgA) 2. Immunoglobulin G (IgG) 3. Immunoglobulin M (IgM) Measurement by using flow cytometry-based assays.

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

• Change from the baseline on the inflammatory cytokines

  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 1. Tumor necrosis factor alpha (TNF-α) 2. Interleukin 1 beta (IL-1β) 3. Interleukin 6 (IL-6) Measurement by using ELISA assay.

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

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

  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.

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

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

  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.

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

• Change from the baseline on the safety parameters (Plasma lipids)

  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 1. Triglyceride 2. Total cholesterol Measurement by using colorimetric assays.

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

• Change from the baseline on the safety parameters (Renal function)

  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 1. Creatinine 2. Total protein Measurement by using colorimetric assays.

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

• Change from the baseline on the safety parameters (Liver function)

  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 1. Aspartate aminotransferase (AST) 2. Alanine aminotransferase (ALT) Measurement by using colorimetric assays.

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

Study Arms (4)

Male received functional beverages

EXPERIMENTAL

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

Dietary Supplement: Functional beverages from the submerged fermentation of Cordyceps militaris

Male received placebo

PLACEBO COMPARATOR

Male received placebo

Other: Fruit juice

Female received functional beverages

EXPERIMENTAL

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

Dietary Supplement: Functional beverages from the submerged fermentation of Cordyceps militaris

Female received placebo

PLACEBO COMPARATOR

Female received placebo

Other: Fruit juice

Interventions

Functional beverages from the submerged fermentation of Cordyceps militaris DIETARY_SUPPLEMENT

The Cordyceps militaris submerged fermentation in fruit juice.

Also known as: FCM

Female received functional beverages; Male received functional beverages

Fruit juice OTHER

Fruit juice is used as a placebo.

Also known as: Placebo

Female received placebo; Male received placebo

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Phayao: lead
• National Innovation Agency (NIA): collaborator

Study Sites (1)

University Of Phayao

Nai Muang, Changwat Phayao, 56000, Thailand

Location

MeSH Terms

Interventions

Fruit and Vegetable Juices

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Atcharaporn Ontawong, Ph.D.

  University of Phayao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr.

Model Details: Male or female received a single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) or placebo.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 18, 2023
• Study Start: November 22, 2022
• Primary Completion: February 10, 2023
• Study Completion: February 28, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)