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HealhtyNCT07344688

The Effect of White Tea in Healthy Human Subjects

A study testing White tea intervention in people with Healhty, run by Universitas Padjadjaran at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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: 1. Determine the effect of white tea consumption on the anthropometry of healthy subjects. 2. Read more about this study

Who is it for?
Ages 20 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Healhty
What is being tested?
White tea intervention
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteIndonesia
Study dates
22 Aug 2025to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Faculty of Pharmacy, Padjadjaran University

    Sumedang, West Java, 45363

Other trials in Indonesia

About this study

Official title: 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)

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:

  1. Determine the effect of white tea consumption on the anthropometry of healthy subjects.
  2. Determine the effect of white tea consumption on the biochemical parameters of healthy subjects.
  3. Determine the effect of white tea consumption on hematology parameters that are related to anemia case in healthy subjects.
  4. Determine the effect of white tea consumption on the activity of first-line antioxidant enzymes in healthy subjects
Read more

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:

  1. Follow the washout stage for 7 days
  2. Drink white tea infusion every day for 14 days.
  3. Follow up to monitor adverse effects after consuming white tea; this stage will be conducted for 7 days.
  4. Report all food and beverages consumed by respondents during the study.
Read the detailed description

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:

  1. 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.
  2. 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.
  3. 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.
Conditions
Healhty
Being tested
White tea intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • White tea interventionOther

    1. White tea infusion was prepared by brewing 4 grams of white tea in 200 mL of hot water.
    2. Healthy respondents were asked to consume the white tea infusion for 14 days.
    3. The focus of this study was to observe the effect of white tea infusion on antioxidant enzyme activity and its relationship with anthropometric, biochemical, and haematological parameters.
Study groups in NCT07344688
Study groupRoleWhat they receive
White tea interventionExperimentalNineteen 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.
Receives: Other: White tea intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 14 days

  2. 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.

    Measured: 14 days

  3. 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

    Measured: 14 days

  4. 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

    Measured: 14 days

  5. Fasting blood glucose measurement

    Fasting blood glucose will be expressed in mmol/L

    Measured: 14 days

  6. 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

    Measured: 14 days

  7. 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

    Measured: 14 days

Secondary outcomes (12)
  1. 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)

    Measured: 14 days

  2. Body Height Measurement

    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).

    Measured: 14 days

  3. 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).

    Measured: 14 days

  4. 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.

    Measured: 14 days

  5. Blood Pressure Measurement

    Both systolic blood pressure or diastolic blood pressure will be measured.

    Measured: 14 days

  6. 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.

    Measured: 14 days

  7. 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.

    Measured: 14 days

  8. 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)

    Measured: 14 days

  9. 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 (%).

    Measured: 14 days

  10. 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).

    Measured: 14 days

  11. 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).

    Measured: 14 days

  12. 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).

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start22 Aug 2025
  3. Primary completion27 Sep 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07344688
Sponsor's protocol ID
PHAR.202509-01
Status last verified
Apr 2026
First submitted
12 Sep 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing White tea intervention in people with Healhty, run by Universitas Padjadjaran at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antioxidant Enzymes Analysis (time frame: 14 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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