A Randomized Controlled Clinical Trial of Cordyceps Militaris Beverage on the Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from the baseline on the physical examination (Weight)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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/m
- •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.
结局指标
主要结局
Change from the baseline on the physical examination (Weight)
时间窗: 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).
Change from the baseline on the physical examination (oxygen saturation)
时间窗: 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 (%).
Change from the baseline on the inflammatory cytokines
时间窗: 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 1. Tumor necrosis factor alpha (TNF-α) 2. Interleukin 1 beta (IL-1β) 3. Interleukin 6 (IL-6) Measurement by using ELISA assay.
Change from the baseline on the safety parameters (Fasting blood glucose)
时间窗: 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.
Change from the baseline on the physical examination (adverse reactions)
时间窗: 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).
Change from the baseline on the immunoglobulins
时间窗: 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 1. Immunoglobulin A (IgA) 2. Immunoglobulin G (IgG) 3. Immunoglobulin M (IgM) Measurement by using flow cytometry-based assays.
Change from the baseline on the immune response (NK cells)
时间窗: 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.
Change from the baseline on the cluster of differentiation (CD) antigens
时间窗: 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 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.
Change from the baseline on physical examination (Height)
时间窗: 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).
Change from the baseline on the physical examination (Blood pressure)
时间窗: 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).
Change from the baseline on the safety parameters (Liver function)
时间窗: 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 1. Aspartate aminotransferase (AST) 2. Alanine aminotransferase (ALT) Measurement by using colorimetric assays.
Change from the baseline on the safety parameters (Complete blood count (CBC))
时间窗: 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.
Change from the baseline on the safety parameters (Plasma lipids)
时间窗: 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 1. Triglyceride 2. Total cholesterol Measurement by using colorimetric assays.
Change from the baseline on the safety parameters (Renal function)
时间窗: 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 1. Creatinine 2. Total protein Measurement by using colorimetric assays.
次要结局
未报告次要终点
研究者
Atcharaporn Ontawong
Assistant Professor Dr.
University of Phayao