Effect of White Tea (Camellia Sinensis L.) Beverages on Anthropometric, Hematological, Biochemical and First Line Antioxidant Enzymes Activity of Healthy Human (Superoxide Dismutase, and Glutathione Peroxidase)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Antioxidant Enzymes Analysis
研究概览
简要总结
This clinical study aims to determine the effects of consuming white tea infusion (Camellia sinensis) on healthy subjects over a period of 14 days. The main questions it aims to answer are:
- Determine the effect of white tea consumption on the anthropometry of healthy subjects.
- Determine the effect of white tea consumption on the biochemical parameters of healthy subjects.
- Determine the effect of white tea consumption on hematology parameters that are related to anemia case in healthy subjects.
- Determine the effect of white tea consumption on the activity of first-line antioxidant enzymes in healthy subjects
Researchers used only one treatment group, and respondents knew which treatment they would receive (single-arm and open-labelled), namely white tea infusion to maintain human body health. Participants will:
- Follow the washout stage for 7 days
- Drink white tea infusion every day for 14 days.
- Follow up to monitor adverse effects after consuming white tea; this stage will be conducted for 7 days.
- Report all food and beverages consumed by respondents during the study.
详细描述
Unhealthy lifestyles, including alcohol consumption, illegal drug use, radiation exposure, and the preparation of food (e.g. smoked meat, used oil, and fat) and polluted environments (water and air pollution) are triggering an increase in cases of degenerative diseases worldwide, including ischaemic heart disease, diabetes, cancer, atherosclerosis, liver disease, kidney disease, chronic obstructive pulmonary disease, and others. The body's natural defences can decline at any time due to the development of reactive oxygen species (ROS) caused by unhealthy lifestyle factors and environmental pollution. Exogenous antioxidants are important for maintaining the body's defence system against excessive ROS. This study will examine the potential of compounds in white tea infusion in maintaining human health by monitoring several parameters, including anthropometric, biochemical, haematological, and antioxidant enzyme activity. The anthropometric parameters tested include body weight, height, waist circumference, systolic blood pressure, and diastolic blood pressure. Biochemical parameters include lipid profile (total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine levels, estimated glomerular filtration rate (eGFR), and urea nitrogen levels. The haematological parameters used are directly related to the indication of anaemia, including red blood cell count, haemoglobin, haematocrit, mean corpuscular haemoglobin (MCH), and mean corpuscular volume (MCV). Finally, there are the first-line antioxidant enzyme activity parameters, including superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx). This examination was conducted before and after the 14-day white tea infusion treatment to observe the effects of the treatment. Male and female healthy volunteers were instructed to follow three stages of research, including:
- Washout phase : respondents are advised to avoid products with high polyphenol content such as turmeric, ginger, galangal, grapes, apples, oranges, coffee, other types of tea, and chocolate, either directly or in processed products.
- Treatment phase: respondents continue to avoid the products avoided during the washout process. In this phase, respondents will consume white tea infusion (4 grams of WT in 200 mL of freshly boiled water) every day for 14 days.
- Observational phase: the phase is conducted for 7 days to monitor the presence or absence of side effects after 14 days of consuming white tea infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participants are the community around Padjadjaran University with an age range of 20 - 35 years old. Female respondents were unmarried.
- •The participants are non-smoker.
- •The participants should have no history of anemia, chronic disease, hepatic and renal dysfunction.
- •The participants are willing to follow the research process until its finish by signing an informed consent form.
排除标准
- •The participants who are undergoing drug therapy and taking vitamin supplements.
- •The participants who failed due to illness or are unable to continue the examination to the end.
- •Respondents with pre-treatment biochemical results not within the normal range
研究组 & 干预措施
White tea intervention
Nineteen respondents will be given 200 mL of white tea (4 grams of white tea sample in 200 mL of water at a temperature of 95-98°C) for 14 days after a 7-day washout period. In the final stage, all respondents will undergo an observation phase. In the final stage, all respondents are required to submit updates on their physical condition. If they experience discomfort such as nausea, dizziness, or general unease, the respondents will be examined by the research physician. In our study, no control group was used. To demonstrate the effect of white tea on the respondents' health condition, we compared the results before and after the treatment.
干预措施: White tea intervention (Other)
结局指标
主要结局
Antioxidant Enzymes Analysis
时间窗: 14 days
Comparing the antioxidant activity values of enzymes including superoxide dismutase, catalase, and glutathione peroxidase in pre and post white tea treatment (day 0 and day 15). The increased activity of antioxidant enzymes signifies an enhancement in the body's capability to combat free radicals. The analysis will be conducted using a reagent kit to obtain the antioxidant enzyme activity values in the respondents' serum. All antioxidant enzyme parameter values are expressed in U/mL.
Liver Function Analysis
时间窗: 14 days
The effect of the product on liver function will be analysed based on SGOT and SGPT values. A drastic increase compared to the pre-intervention level indicates potential toxicity. Both parameters will be expressed in units of ukat/L.
estimated Glomerular filtration rate
时间窗: 14 days
A drastic decrease in eGFR indicates the potential toxicity of white tea beverages. eGFR results of respondents will be expressed in mL/min/1.73m2
Lipid profile measurement
时间窗: 14 days
The effect of product administration on lipid profile was assessed by measuring total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) parameters. Product effectiveness was determined based on the stability or decrease in total cholesterol, triglycerides, and LDL values, as well as an increase in HDL values post-treatment compared to pre-treatment values. Total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) will be expressed in mmol/L
Fasting blood glucose measurement
时间窗: 14 days
Fasting blood glucose will be expressed in mmol/L
Serum creatinine Analysis
时间窗: 14 days
An elevated serum creatinine level is an indication of potential toxicity associated with white tea consumption. Serum creatinine level will be expressed in umol/L
Blood Urea Nitrogen Analysis
时间窗: 14 days
An elevated blood urea nitrogen level is an indication of potential toxicity associated with white tea consumption. The parameter will be written in units of mmol/L
次要结局
- Body Weight Measurement(14 days)
- Body Height Measurement(14 days)
- Body Mass Index(14 days)
- Waist Circumference Measurement(14 days)
- Blood Pressure Measurement(14 days)
- Number of participants with serious adverse events related to study product(14 days)
- Red Blood Cells Measurement(14 days)
- Haemoglobin Measurement(14 days)
- Haematocrit Measurement(14 days)
- Mean Corpuscular Haemoglobin Measurement(14 days)
- Mean Corpuscular Volume Measurement(14 days)
- Daily intake(28 days)