The Effect of White Tea in Healthy Human Subjects

NCT07344688 | Completed DMC

• 1 other identifier: PHAR.202509-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine the effect of white tea consumption on the anthropometry of healthy subjects.
2. 2.Determine the effect of white tea consumption on the biochemical parameters of healthy subjects.
3. 3.Determine the effect of white tea consumption on hematology parameters that are related to anemia case in healthy subjects.
4. 4.Determine the effect of white tea consumption on the activity of first-line antioxidant enzymes in healthy subjects
5. 5.Follow the washout stage for 7 days
6. 6.Drink white tea infusion every day for 14 days.
7. 7.Follow up to monitor adverse effects after consuming white tea; this stage will be conducted for 7 days.
8. 8.Report all food and beverages consumed by respondents during the study.

Conditions

Healhty

Outcome Measures

Primary Outcomes (7)

• 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

• 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

Secondary Outcomes (12)

• 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

Study Arms (1)

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.

Other: White tea intervention

Interventions

White tea intervention OTHER

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.

White tea intervention

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Faculty of Pharmacy, Padjadjaran University

Sumedang, West Java, 45363, Indonesia

Location

Study Officials

• Gofarana Wilar, Ph.D.

  Faculty of Pharmacy, Universitas Padjadjaran, Bandung, Indonesia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: January 15, 2026
• Study Start: August 22, 2025
• Primary Completion: September 27, 2025
• Study Completion: December 30, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

ID (1)