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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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White tea intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White tea intervention | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Antioxidant Enzymes Analysis | 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. | 14 days |
| Liver Function Analysis | 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. | 14 days |
| estimated Glomerular filtration rate | 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 | 14 days |
| Lipid profile measurement | 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 | 14 days |
| Fasting blood glucose measurement | Fasting blood glucose will be expressed in mmol/L | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Measurement | The body weight of respondents will be measured on day 0 and day 15 after administration of white tea treatment. Body weight values before and after treatment will be analysed. Body weight values will be recorded in kilograms (kg) | 14 days |
| Body Height Measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gofarana Wilar, Ph.D. | Faculty of Pharmacy, Universitas Padjadjaran, Bandung, Indonesia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Padjadjaran University | Sumedang | West Java | 45363 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2026 | Jan 7, 2026 | Prot_SAP_000.pdf |
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| Serum creatinine Analysis | 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 | 14 days |
| Blood Urea Nitrogen Analysis | 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 | 14 days |
Height measurements will be taken on days 0 and 15. Measurements will be taken to calculate BMI values for further analysis. Height values will be recorded in centimetres (cm). |
| 14 days |
| Body Mass Index | Body mass index measurements will be taken using weight and height data. The BMI result is recorded in kg/m^2, then the analysis will be classified into the categories of underweight (BMI range <18.5 kg/m^2) healthy (BMI range 18.5 - 24.9 kg/m^2), overweight (BMI range 25.0 - 29.9 kg/m^2) and obese (BMI range > 29.9 kg/m^2). | 14 days |
| Waist Circumference Measurement | Waist circumference measurements were taken on days 0 and 15 using a measuring tape and expressed in centimetres (cm). The results before and after treatment will be analysed. | 14 days |
| Blood Pressure Measurement | Both systolic blood pressure or diastolic blood pressure will be measured. | 14 days |
| Number of participants with serious adverse events related to study product | Signs and symptoms of adverse event related to study product including nausea, vomiting, dizziness, burning sensation in the stomach, excessive fatigue, constipation, and excessive urination will be assessed daily for 14 days since the first administration of white tea beverages. | 14 days |
| Red Blood Cells Measurement | Red blood cell (RBC) parameters are one of the parameters used to assess whether white tea beverages have the potential to cause anaemia. Tests were conducted on days 0 and 15, the difference in RBC values was analysed, and RBC values were expressed in 10^6/uL. | 14 days |
| Haemoglobin Measurement | Haemoglobin parameters are one of the parameters used to assess whether white tea beverages have the potential to cause anaemia. Tests were conducted on days 0 and 15, the difference in haemoglobin values was analysed, and haemoglobin values were expressed in grams/decilitre (g/dL) | 14 days |
| Haematocrit Measurement | Haematocrit parameters are one of the parameters used to assess whether white tea beverages have the potential to cause anaemia. Tests were conducted on days 0 and 15, the difference in haematocrit values was analysed, and haematocrit values were expressed in percentage (%). | 14 days |
| Mean Corpuscular Haemoglobin Measurement | Mean Corpuscular haemoglobin (MCH) parameters are one of the parameters used to assess whether white tea beverages have the potential to cause anaemia. Tests were conducted on days 0 and 15, the difference in MCH values was analysed, and MCH values were expressed in picograms (pg). | 14 days |
| Mean Corpuscular Volume Measurement | Mean Corpuscular Volume (MCV) parameters are one of the parameters used to assess whether white tea beverages have the potential to cause anaemia. Tests were conducted on days 0 and 15, the difference in MCV values was analysed, and MCV values were expressed in femtoliters (fL). | 14 days |
| Daily intake | The daily report of respondents incorporates information regarding their daily activities and the consumption of food and beverages during the 28-day research period. Respondents will be asked to submit this data every day via personal chat (WhatsApp). | 28 days |