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| Name | Class |
|---|---|
| National Innovation Agency (NIA) | UNKNOWN |
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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.
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 :
Exclusion Criteria :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male received functional beverages | Experimental | Male received single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) |
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| Male received placebo | Placebo Comparator | Male received placebo |
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| Female received functional beverages | Experimental | Female received single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) |
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| Female received placebo | Placebo Comparator | Female received placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional beverages from the submerged fermentation of Cordyceps militaris | Dietary Supplement | The Cordyceps militaris submerged fermentation in fruit juice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atcharaporn Ontawong, Ph.D. | University of Phayao | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Phayao | Nai Muang | Changwat Phayao | 56000 | Thailand |
Prohibited from laws (contracts)
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| ID | Term |
|---|---|
| D000067030 | Fruit and Vegetable Juices |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Male or female received a single oral dose of functional beverages from submerged fermentation of Cordyceps militaris (FCM) or placebo.
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| Fruit juice | Other | Fruit juice is used as a placebo. |
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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
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
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
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
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
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
Measurement by using colorimetric assays. | At 0, 4 and 8 weeks after end of the intervention |