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)
Phase: NA
Conditions: Healhty
Sponsor: Universitas Padjadjaran

Protocol title: 
EFFECT OF WHITE TEA (Camellia sinensis L.) BEVERAGES ON 
ANTHROPOMETRIC, HEMATOLOGICAL, BIOCHEMICAL AND FIRST LINE 
ANTIOXIDANT ENZYMES ACTIVITY OF HEALTHY HUMAN (SUPEROXIDE 
DISMUTASE, CATALASE, AND GLUTATHIONE PEROXIDASE) 
 
 
Number of protocols: 
Version: 1.0 
 
Document date: 
January 7th, 2026 
 
 
 
Research Team: 
Lidya Cahyo Bawono, S.Si., M.Farm. 
apt. Gofarana Wilar, Ph.D. 
Dr. apt. Ellin Febrina, M.Si. 
Prof. Madya Dr. Norazrina Azmi 
 
 

Principal Researcher 
Name   : Lidya Cahyo Bawono, S.Si., M.Farm. 
Adress : Raya Bandung Sumedang street KM 21 
Hegarmanah, Jatinangor, Sumedang, 
West Java 
Phone  : +6285747404360 
Research Team 1 
Name    : apt. Gofarana Wilar, Ph.D 
Adress  : Raya Bandung Sumedang street KM 
21 Hegarmanah, Jatinangor, 
Sumedang, West Java 
Phone   : +6281297574112 
Research Team 2 
Name    : Dr. Apt Ellin Febrina, M.Si 
Adress  : Raya Bandung Sumedang street KM 
21 Hegarmanah, Jatinangor, 
Sumedang, West Java 
Phone   : +6281320514511 
Research Team 3 
Name    : Prof. Madya Dr. Norazrina Azmi 
Adress  : Raja Muda Abdul Aziz street, Kuala 
Lumpur, Malaysia. 
Phone   : +60126537076 
Research Place 
Faculty of Pharmacy, Padjadjaran University. 
Sumedang, Indonesia 
Contact person 
Lidya Cahyo Bawono, S.Si., M.Farm. 
Apt. Gofarana Wilar, Ph.D 
Dr. Ellin Febrina, M.Si 
Clinical Laboratory 
Bandung City Health Office, Cihapit. Bandung, 
West Java, Indonesia 
Biomed. Laboratory 
Faculty of Medicine, Padjadjaran University, 
Bandung, Indonesia 
Archiving samples and raw data 
 
Sample archiving will be placed in a locked 
cabinet in the Pharmacology Laboratory, Faculty 
of Pharmacy, Padjadjaran University.   
 
 
 

1. 
PROTOCOL RESUME 
1.1. Protocol Resume 
Protocol title:  
Effect of White Tea (Camellia sinensis L.) Beverages on Anthropometric, 
Hematological, Biochemical and First Line Antioxidant Enzymes Activity of Healthy 
Human (Superoxide Dismutase, Catalase, and Glutathione Peroxidase) 
 
Research aims:  
Understanding the potential of white tea for human health in terms of anthropometry 
(body weight, body mass index and waist circumference), blood pressure and 
biochemistry (lipid profile, blood glucose levels and antioxidant enzyme activity). 
Furthermore, the safety of white tea products will be evaluated by means of 
haematological parameters (red blood cells, haematocrit, haemoglobin, mean corpuscular 
volume (MCV), and mean corpuscular haemoglobin (MCH)), liver parameters (alanine 
aminotransferase (ALT) and aspartate aminotransferase (AST)), and renal parameters 
(creatinine levels, estimated glomerular filtration rate (eGFR), and blood urea nitrogen) 
following a 14-day period of white tea consumption. 
  
Study design:  
This study will combine a pilot study with a pre-post quasi-experimental design.  
  
 
Specific aims 
1. Determine the effect of white tea consumption on the anthropometry of healthy 
subjects based on body weight, body mass index, waist circumference, and blood 
pressure.  
2. Determine the effect of white tea consumption on the biochemical parameters of 
healthy subjects based on blood glucose, 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. 
3. Determine the effect of white tea consumption on blood parameters in healthy 
subjects based on red blood cell count, haemoglobin, haematocrit, mean 
corpuscular haemoglobin (MCH), and mean corpuscular volume (MCV). 
4. Determine the effect of white tea consumption on the activity of first-line 
antioxidant enzymes (superoxide dismutase, catalase, and glutathione 
peroxidase) in healthy subjects. 
 
Pre-post quasi-experimental study design 
The present study was conducted over a period of 14 days with the aim of observing the 
effects of white tea consumption on anthropometric parameters, blood pressure, 
haematology, biochemistry, and antioxidant enzymes activity. Prior to the intervention, 
subjects were instructed to undergo a washout phase. During the washout phase, subjects 
were instructed to refrain from consuming vitamins, herbal drinks containing spices 
(turmeric, ginger, and galangal), fruits with high flavonoid content (grapes, apples, 
oranges, and their processed products), and products containing high levels of tannins 
(coffee, other types of tea, and chocolate). This approach was adopted to mitigate 
potential bias and to avert the occurrence of anemia or other forms of toxicity. 

Subsequently, a series of anthropometric, blood pressure, complete haematology, and 
biochemistry tests are conducted to ascertain which subjects meet the criteria to proceed 
to the research stage. Subjects who meet the specified criteria will then be educated on 
the art of tea-making and instructed to consume it for a period of 14 days. During the 
administration stage of white tea, subjects are instructed to refrain from using the 
products that they abstained from during the washout stage. Anthropometric 
measurements, blood pressure, complete haematology, and biochemistry tests will be 
performed again on day 15 and the day after last day white tea administration. 
Subsequently, all subjects will undergo a period of post-intervention monitoring (the 
observation phase) for a duration of seven days. The purpose of this monitoring is to 
ensure that no deleterious effects result from the white tea intervention. 
 
Sample Size Calculation 
This study is a pilot study, and the minimum sample size calculation will be performed 
using the thumb method through an NCT approach with 90% power and a significance 
value of 5%. The calculation indicated that, given a 20% attrition rate, a sample size of 
19 subjects was required for the study. 
 
Subject: 
The total number of subjects included in the study was 19, with an age range of 20-35 
years (excluding women who were either unmarried or sexually inactive). These subjects 
resided in the vicinity of Padjadjaran University and had provided written consent by 
signing an informed consent form. The subjects must be in good health, have not been 
active smokers for a period of less than five years, and have no history of anaemia, 
cardiovascular disease, or liver and kidney disorders. The exclusion criteria employed 
are outlined below:  
a. Participants were required to take certain medications or vitamin supplements. 
b. The subjects reported experiencing discomfort during the administration of the 
product. 
c. Prior to the initiation of treatment, biochemical results were found to be outside the 
normal range. 
 
Consent to Respondents 
Informed consent will be requested by the research team before the washout period 
begins. Consent will be given in writing in the form of a signed consent form by the 
respondents. 
 
Respondents Recruitment 
The patient recruitment process was executed through the dissemination of 
advertisements utilising Google Forms, which were subsequently propagated via social 
media WhatsApp groups and Instagram. Following an initial screening process based on 
the information provided in the Google Forms by prospective research subjects, the 
research team made a selection based on inclusion criteria to obtain patients who met the 
specified criteria.    
 
Test Product 
The test product provided was 4 grams of white tea, packaged in a tea bag. The 
respondents were instructed to brew one tea bag in 200 mL of hot water for 10 minutes. 
The ingestion of the white tea should be scheduled for one hour prior to or two hours 
after breakfast. 

 
Monitoring During Intervention 
During the white tea intervention process, subjects will be monitored for food and 
beverage intake and daily activities. Please refer to Appendix 1 for a comprehensive 
overview of the daily data.  
 
Research Duration 
The research is estimated to take 28 days, including the first seven days for the washout 
phase, the second 14 days for the intervention phase, and the last seven days for the 
observational stage. This is to ensure that the subjects do not experience any serious 
effects as a result of the research. 
 
Data Collection 
All data pertaining to the study will be stored on CRFs/individual screening sheets. The 
data will be recorded in both soft and hard file formats on a daily basis. 
 
Evaluation Criteria 
Anthropometric measurements, blood pressure, haematology, and biochemistry tests will 
be conducted before the intervention and one day after the last intervention (day 0 and 
day 15). Anthropometric measurements, blood pressure, and blood sampling will be 
conducted at the Faculty of Pharmacy, Padjadjaran University. The biochemical 
examinations will be carried out at the clinical laboratory of the Bandung City Health 
Office, while the complete haematology and antioxidant enzyme examinations will be 
carried out at the Biomedical Laboratory of the Faculty of Medicine, Padjadjaran 
University. The results of the examinations conducted before and after the white tea 
intervention will be analyzed to ascertain the effect of white tea consumption over a 
period of 14 days. The types of food and beverages consumed by the research subjects 
and their daily activities were recorded in the CRF for a period of 28 days (from the 
wash-out phase to the observational phase).  
 
Statistical Analysis 
The effect of white tea administration will be compared before and after treatment using 
a t-test analysis.  
 
 

1.2. Proposal Summary 
Background 
In the contemporary era, there is a general consensus that individuals have the capacity 
to procure a wide variety of goods and services with ease. A pertinent example of this 
phenomenon is the accessibility of food. A significant proportion of the population may 
be unconsciously adopting unhealthy lifestyles, characterised by the consumption of junk 
food in place of healthy foods, and an insufficient amount of exercise and rest, potentially 
attributable to their demanding workloads. These factors are supported by rapid industrial 
development, which also contributes to increased pollution, thereby increasing the 
production of free radicals in the human body. It is evident that the excessive and 
protracted generation of free radicals will exert a substantial influence on the onset of 
degenerative diseases, including cardiovascular disease, diabetes mellitus, cancer, and 
other grave pathologies.  
 
The objective of the present study is to assess the antioxidant potential of white tea, with 
a view to providing the public with a reference point for high-antioxidant products that 
are more convenient and safer to consume. White tea has been shown to be effective in 
other countries, such as China, but the potential of white tea produced in Indonesia has 
not yet been extensively investigated. Geographical differences in the cultivation of tea 
have been demonstrated to result in discrepancies in content and effects. In the event of 
efficacy being demonstrated, it would be beneficial to conduct further testing of its 
potential in other, more specific diseases. Patients who meet the specified criteria will be 
instructed to consume white tea for a period of 14 consecutive days, while ensuring that 
they avoid the consumption of products that are rich in antioxidants, such as vitamins, 
herbal drinks (turmeric, ginger, and galangal), fruits with high flavonoid content (grapes, 
apples, oranges and their processed products), and products containing high tannin 
compounds (coffee, other types of tea, and chocolate). During the white tea consumption 
phase, subjects will be asked to report their daily food and beverage intake, as well as 
their daily activities. Clinical examinations will be conducted in two phases: the first 
prior to the administration of white tea, and the second after a 14-day period of white tea 
consumption. The data will be examined and compared before and after the 
administration of white tea to analyze the effects of white tea on human health. Should 
the study demonstrate a satisfactory degree of potential, it may be utilised as a point of 
reference to ascertain its broader potential for the treatment of specific diseases.  
 
Metodologi 
This study will analyze the potential effects of consuming white tea for 14 consecutive 
days. During the 7 days prior to white tea consumption (wash-out stage) and the 14 days 
during white tea consumption (treatment stage), all research subjects were instructed to 
avoid consuming products high in flavonoids, such as vitamins, herbal drinks containing 
spices (turmeric, ginger and kencur), fruits high in flavonoids (grapes, apples, oranges 
and their processed products), and products containing high levels of tannins (coffee, 
other types of tea, and chocolate). This was done to avoid excessive flavonoid intake, 
which can trigger anaemia and the formation of pro-oxidants. In addition, the presence 
of other strong antioxidants can also cause errors in the test (leading to bias) due to the 
influence of other antioxidant products. Furthermore, all respondents will be asked to 
drink white tea (made by brewing 4 grams of white tea in 200 mL of hot water) every 
morning one hour before eating or two hours after eating. To ensure the compliance of 
the research subjects, we will ask respondents to send videos of themselves consuming 
white tea, monitor and record the food and drinks consumed by all subjects in the CRF. 

White tea is a type of tea that is believed to have better antioxidant content than other 
types of tea due to its high content of flavonoid compounds, especially catechins. If 
regular consumption of white tea for 14 days is proven to have a positive effect on 
anthropometric parameters, lipid profile, blood sugar levels and increases antioxidant 
enzyme activity, and is proven to be safe when reviewed from haematological 
parameters, ALT, AST, serum creatinine levels and eGFR, then this product can be 
further developed as a product for adjuvant therapy in various types of diseases. This 
study was conducted as an initial test of the potential of white tea for health before further 
exploration for application to a specific disease.  
 
1.3. List of Abbreviations and Definitions 
ALT 
: Alanine aminotransferase 
APOB : Apolipoprotein B 
AST 
: Aspartate aminotransferase 
BMI 
: Body mass index 
CAT 
: Catalase 
CRF 
: Case Report Form 
EDTA : Ethylene Diamine Tetra acetic Acid 
EGCG : Epigallocatechin Gallate 
EGC 
: Epigallocatechin 
eGFR 
: estimated Glomerular Filtration Rate 
GPx 
: Glutathione Peroxidase 
Hb 
: Hemoglobin 
HCT 
: Hematocrit 
HDL 
: High-density Lipoprotein 
LDL 
: Low-density Lipoprotein 
LDLR : Low-density Lipoprotein Receptor 
MCV 
: Mean Corpuscular Volume 
MCH 
: Mean Corpuscular Hemoglobin 
MTTP : Microsomal Triglyceride Transfer Protein 
RBC 
: Red Blood Cells 
ROS 
: Reactive Oxidative Stress 
SOD 
: Superoxide Dismutase 
 
 

2. 
Introduction 
2.1. Background 
Reactive oxygen species (ROS) are natural products of oxygen metabolism in living cells 
(1–3). Excessive ROS production triggers oxidative stress in the human body (4, 5). The 
long-term exposure to oxidative stress has been demonstrated to be a contributing factor 
to the development of several degenerative diseases, including cardiovascular disease, 
cancer and various other chronic conditions. These diseases currently represent the 
leading causes of mortality in the human population (6–8). In 2019, the global mortality 
rate was 28% higher than in 2000. The number of cardiovascular disease cases in 
Indonesia reached 2,784,064, while diabetes mellitus cases reached 16 million (9). The 
World Health Organization (WHO) also reports cancer as the leading cause of death 
worldwide, with 10 million deaths in 2020 (10, 11).  
 
The prevalence of degenerative diseases in contemporary society is attributable to a 
multitude of factors, chief among which is an unhealthy lifestyle that engenders excessive 
ROS formation. Antioxidants are vital for neutralizing and reducing ROS production in 
the body. White tea (Camellia sinensis) is one such antioxidant whose potential for 
exploration is significant (12). Catechins and polysaccharides have been identified as the 
bioactive compounds responsible for the wide range of biological activities exhibited by 
white tea, which include hypoglycemic, hypolipidemic, and antioxidant properties (13). 
Previous studies have reported that EGCG and EGC are capable of regulating gene 
expression in cholesterol metabolism, such as low-density lipoprotein receptor (LDLR), 
microsomal triglyceride transfer protein (MTTP), and apolipoprotein B (APOB) (14).  
Supported by other studies, white tea has been shown to suppress the adipogenesis 
process by increasing lipolytic activity (15). It has been documented that white tea has 
the capacity to reduce creatinine and blood urea nitrogen levels in female rats afflicted 
with kidney disorders induced by cisplatin (16). As demonstrated in our preceding 
preclinical research, a dose-response relationship has been observed between white tea 
consumption and several parameters, including ALT, AST, lipid profile, red blood cells, 
haematology, and haematocrit, in healthy rats. It was hypothesised that the most 
significant increase in ALT and AST values would occur at higher doses. This hypothesis 
was tested, and it was concluded that 0.072 mg/day of white tea (equivalent to a human 
dose of 4 g/day) was more effective than 0.144 mg/day (equivalent to a human dose of 8 
g/day). This phenomenon may be attributable to the production of pro-oxidants, a 
consequence of the elevated antioxidant content present in high concentrations of white 
tea. The objective of this study was twofold: firstly, to analyze the effectiveness of a 4 
g/day dose in humans on human health parameters; and secondly, to ensure the safety of 
using this dose for 14 days. 
   
2.2. Product Dosage  
The dosage employed in the clinical trials pertains to in vivo studies conducted on both 
normal Wistar rats and CCl4-induced rats, with varying doses of white tea ranging from 
0.072 to 0.144 milligrams per kilogram of body weight, administered over a period of 14 
days. In consideration of the findings and the outcomes of an analysis of numerous 
parameters, including complete haematology (RBC, Hb, Hct, MCV and MCH), 
biochemistry (ALT, AST, total cholesterol, LDL, HDL and triglycerides), and 
antioxidant enzyme activity (SOD, CAT, and GPx), it was determined that a dose of 
0.072 mg/kg BW exhibited the most efficacious and secure effect on these parameters. 
The 0.072 mg/kg BW dose for rats was adopted from the conversion of a 4 gram/day 

human dose. The present study will utilize a dosage of 4 grams of white tea in 200 
millilitres of water, to be consumed on a daily basis for a period of 14 days. 
 
2.3. Known Risks and Potential Health Benefits of White Tea Consumption 
Possible risks associated with drinking white tea that have been studied:     
• White tea contains theophylline and caffeine (17). Theophylline has been 
demonstrated to induce acid reflux, a factor which can precipitate the development of 
erosive oesophagitis. Consequently, the burning sensation experienced by the subject 
may be attributable to elevated levels of theophylline entering the body. The presence 
of caffeine in white tea has been demonstrated to induce adverse effects, including 
symptoms such as nausea and vomiting.  
• Caffeine, a stimulant compound found in tea, has been observed to induce calcium 
release, thereby facilitating increased muscle contractions. Furthermore, it has been 
demonstrated that caffeine can induce the secretion of stimulatory agents such as 
prostaglandin, adenosine triphosphate, acetylcholine and nitric oxide from the 
urothelium, thereby stimulating augmented urine production in the bladder (18). 
• Catechins, a type of polyphenol found in white tea, have been shown to possess 
therapeutic benefits in treating various diseases. However, in excessive doses, they 
have the potential to cause excessive pro-oxidant effects, triggering inflammatory 
reactions, necrosis and steatosis in the liver (18). 
• The high polyphenol content of white tea has been demonstrated to have a potential 
inhibitory effect on iron absorption, which may consequently result in iron deficiency 
and the subsequent development of anaemia (19–21). 
 
Benefits associated with drinking white tea that have been studied: 
• Catechins and polysaccharides are believed to be responsible for the broad biological 
activity exhibited by white tea, which includes hypoglycaemic, hypolipidaemic, and 
antioxidant properties (13).  
• The ingestion of green tea (Camellia sinensis) for a period of two months has been 
demonstrated to engender favourable outcomes in elderly subjects afflicted with 
metabolic syndrome. These outcomes encompass a reduction in weight, BMI, and 
waist circumference (22).  
• The administration of three cups of green tea infusion (7.5 g/day) has been 
demonstrated to enhance the lipid profile in patients with T2DM nephropathy, without 
compromising renal function (23).  
• It has been demonstrated that EGCG, a polyphenol compound found in green tea, 
possesses the ability to regulate glucose homeostasis by promoting glucose uptake in 
adipocytes, reducing insulin resistance, and decreasing blood glucose levels (24).  
• Green tea (600 mL/day) for 4 weeks was reported to maintain the health of healthy 
respondents. This was evidenced by no significant changes in haematological profile 
(RBC, Hb, Hct, MCV, and MCH), serum creatinine, eGFR, and serum urea (25).  
• The ingestion of three cups of green tea (100 mL per cup) per day has been 
demonstrated to enhance the activity of superoxide dismutase (SOD), catalase (CAT), 
glutathione (GSH), and glutathione peroxidase (GPx) in chronic smokers(26). 
 
3. 
REASONS AND OBJECTIVES OF THE RESEARCH 

3.1. Justification for Study 
A plethora of studies conducted in various countries, including China, Japan, and Turkey, 
have demonstrated the health benefits of white tea, including its potential as an 
anticancer, anti-obesity, antihyperlipidemic, and antidiabetic agent. Geographical 
differences in the countries where Camellia sinensis tea is cultivated will affect its 
chemical composition. A review of the extant literature reveals a paucity of studies 
exploring the potential of white tea from Indonesia for human health. The present study 
will examine the antioxidant capacity of white tea, with a view to providing new 
references for the public regarding white tea products as antioxidants that can be used as 
products to improve public health. 
 
3.2. Research objectives 
The objectives of this study are:   
1. Determine the effect of white tea consumption on the anthropometry of healthy subjects 
based on body weight, body mass index (BMI), waist circumference, and blood 
pressure.  
2. Determine the effect of white tea consumption on biochemical parameters in healthy 
subjects based on blood sugar levels, complete lipid profile (total cholesterol, low-
density lipoprotein, high-density lipoprotein, and triglycerides), liver function activity 
(based on liver enzyme function including alanine aminotransferase and aspartate 
aminotransferase), and kidney function (through measurement of creatinine levels, 
estimated glomerular filtration rate, and urea nitrogen levels). 
3. Determine the effect of white tea consumption on hematology profile parameters 
associated with anaemia, including total red blood cell count, haemoglobin, 
haematocrit, mean corpuscular haemoglobin (MCH), and mean corpuscular volume 
(MCV). 
4. Determine the effect of white tea consumption on the first line antioxidant enzymes 
activity of healthy subjects, such as superoxide dismutase, catalase, and glutathione 
peroxidase.  
 
4. 
STUDY DESIGN 
The present study adopts a quasi-experimental design, conducted as a pilot study, with 
the objective of ascertaining the effect of white tea consumption on several human health 
parameters. These parameters include anthropometry, blood pressure, haematology, 
biochemistry, and antioxidant enzyme activity. The study is divided into three stages. 
Firstly, a washout stage is conducted over the first seven days. This is followed by an 
intervention/treatment stage for 14 days, which is conducted one day after blood 
sampling. Finally, an observation stage is conducted for the last seven days to ensure that 
the subjects are in good condition after the intervention.  
 
5. 
RESEARCH LOCATION 
The research will be conducted in several locations, including: 
1. Faculty of Pharmacy, Padjadjaran University. 
2. Biomedical Laboratory, Faculty of Medicine, Padjadjaran University. 
3. Clinical Laboratory, Bandung City Health Office, Bandung, West Java.  
 
6. 
TARGET POPULATION AND SAMPLE SIZE 

The population utilised in this study comprised healthy subjects residing at Padjadjaran 
University and its environs who had completed the recruitment form on Google Forms. 
The respondents' data that had been entered underwent preliminary screening based on 
the following inclusion and exclusion criteria. 
 
Inclussion criteria 
a. Participants are members of the Padjadjaran University community and surrounding 
areas aged 20-35 years (excluding women who were either unmarried or sexually 
inactive). 
b. Participants must not have been smokers for less than 5 years. 
c. Participants must not have a history of anaemia, liver or kidney disease. 
 
Exclussion criteria 
a. Participants were required to take certain medications or vitamin supplements. 
b. The subjects reported experiencing discomfort during the administration of the 
product. 
c. Prior to the initiation of treatment, biochemical results were found to be outside the 
normal range.  
 
This study utilised a pilot study, and the minimum sample size calculation was performed 
using the thumb method with a non-central t-distribution (NCT) approach. Whitehead 
stated that the minimum sample size for a power (β) value of 90% and a significance (α) 
value of 5% is 15 for each group. Considering a 20% possibility of dropouts, we used 19 
subjects in the study. The following table provides a reference for the calculation of the 
sample size, as outlined by Whitehead et al. (2016) (27). 
 
 
 
7. 
RESEARCH PROCEDURE 
7.1. Recruitment of Respondents and Initial Screening 
The data collected from respondents will undergo a review and selection process, with 
this being based on predetermined inclusion and exclusion criteria. A proportion of 
respondents who meet the specified criteria will be directed to undergo a 7-day washout 
period. The purpose of this procedure is to prevent bias in the initial screening process. 
During this phase, subjects are instructed to avoid the consumption of vitamins, herbal 
drinks containing spices (turmeric, ginger and galangal), fruits with high flavonoid 
content (grapes, apples, oranges and their processed products), and products containing 
high levels of tannins (coffee, other types of tea, and chocolate).  
 
7.2. Procedures for Requesting Permission from Research Subjects 
Patients who are deemed to be eligible will be provided with an explanation of the 
research process and will be requested to provide their voluntary consent. As the 
population under study consists of adults in good health, consent must be obtained 
directly from the participant via a process of signing the consent form after receiving an 

explanation (informed consent). The signing process will be initiated subsequent to the 
subject being deemed to have comprehended the explanation pertaining to the research. 
The signing process will be carried out by the respondent, the researcher, and a witness 
who will observe the consent process. 
 
7.3. Respondents Selection 
Patients who have been declared eligible during the preliminary screening and have 
signed the consent form will be provided with instructions on how to prepare the tea. It 
is imperative that the CRF be completed in a manner that is both legible and exhaustive. 
 
7.4. Provision of Test Products 
Following the endorsement of the consent form, each subject will be furnished with a set 
of fourteen tea bags, each containing four grams of white tea. These tea bags will be 
accompanied by comprehensive instructions detailing the optimal preparation of the tea. 
Subjects are instructed to brew one tea bag in hot water for 10 minutes. The tea must be 
consumed one to two hours after breakfast for a period of 14 days.   
 
Product Storage 
White tea products should be stored in a sealed container at room temperature. 
 
Guarantee of research subject compliance 
Subject compliance will be monitored each morning by asking subjects to send a video 
of themselves drinking the beverage product every day. 
  
7.5. Respondent Monitoring 
Monitoring of anthropometry and blood pressure 
The subjects of the research will undergo physical monitoring, including weight, height, 
BMI, waist circumference and blood pressure, by research team on days 0 and 15 (one 
day before and one day after the last day of the white tea intervention).  
 
Laboratory monitoring 
Laboratory monitoring was conducted on days 0 and 15 (one day before and one day 
after the last day of the white tea intervention) on blood samples from subjects in order 
to determine the effects of drinking tea for a period of 14 days. Should the preliminary 
investigative results pertaining to haematological parameters (RBC, HB, HCT, MCV and 
MCH), ALT, AST, serum creatinine levels, eLFG and urea nitrogen levels demonstrate 
abnormality, the subject will be withdrawn from the study for reasons of safety. 
Haematological tests are performed to ensure that the subject is not anaemic. ALT and 
AST tests are performed to ensure that there is no liver dysfunction, while serum 
creatinine, eGFR, and urea nitrogen tests are performed to ensure that the subjects do not 
have kidney dysfunction. In summary, the parameters employed in this study to observe 
the effects of white tea consumption are outlined as follows: 
a. Hematology profile  
b. Lipid profil 
c. Fasting blood glucose 
d. ALT dan AST 
e. Serum creatinine level, urea nitrogen level and eGFR 
f. First line antioxidant enzymes (SOD, CAT dan GPx). 
 

Monitoring consumption and daily activities 
In order to ensure that respondents adhere to the prescribed dietary regime, researchers 
will ensure that subjects abstain from the consumption of particular products that must 
be avoided during the course of the research process. Researchers will record all food 
and beverages consumed, the subjects' daily activities, and any complaints that may be 
experienced by the subjects, whether related or unrelated to the administration of white 
tea products. 
 
7.6. Discontinuation of Respondent Involvement in Research 
Research subjects may withdraw from participation in the study, and researchers may 
also terminate a subject's involvement in the study if there is a deviation from the 
protocol. If a research subject is terminated for medical reasons, the researcher will 
ensure that their health is monitored until their condition improves. 
 
7.7. Anthropometric Measurement  
Measurements of body weight, height, and waist circumference for the study will be 
taken on day 0 (one day before the intervention) and day 15 (one day after the last day of 
the white tea intervention). Participants are advised to wear light clothing and remove 
their shoes before weight and height measurements. BMI values will be calculated using 
an 
online 
BMI 
calculator 
based 
on 
weight 
(kg) 
and 
height 
(cm) 
(nhlbi.nih.gov/health/education/lose_wt/BMI/bmi-m.htm). 
 
7.8. Blood Pressure  Measurement 
Concurrently, blood pressure assessments will be conducted on the day of blood 
sampling. The protocol for conducting blood pressure tests is outlined as follows: 
a. Participants are asked to rest for 5 minutes before blood pressure measurement without 
talking during the rest period. 
b. Participants are asked to sit upright with their back against the chair, ensuring that both 
feet are flat on the floor. 
c. Blood pressure measurement will be taken in a sitting position with the sleeve of the shirt 
open.  
d. The sphygmomanometer is placed on the right or left arm approximately 3 cm above the 
elbow crease. The arm cuff should not be too tight or too loose. 
e. The start button on the sphygmomanometer monitor is pressed. Blood pressure 
measurements will be taken three times, with a 1-minute interval between each 
measurement. 
f. 
The systolic and diastolic pressure results are recorded. 
 
7.9. Hematology Profile Measurement 
Haematological analysis will be conducted at the clinical laboratory of the Bandung 
District Health Office. Blood samples were collected on day 0 (one day before the 
intervention) and day 15 (one day after the last day of the white tea intervention). The 
samples were stored in EDTA tubes and analyzed using an Erba H360 automatic 
haematology analyzer. 
 
7.10. Biochemical Measurement 
The investigation involved the performance of a comprehensive array of analytical 
procedures, including lipid profile, blood glucose, blood urea nitrogen, serum creatinine, 
ALT and AST tests. These were conducted at the Bandung District Health Office clinical 
laboratory, employing the utilisation of a Cobas C 311 biochemical automatic analyzer.  

 
7.11. estimated Glomerular Filtration Rate Value Measurement 
The creatinine level obtained will be used to calculate the eGFR value. The eGFR value 
will be calculated using an online calculator based on creatinine level, age, and gender. 
(https://kidney.org.au/health-professionals/egfr-calculator). 
 
7.12. Antioxidant Enzymes Analysis 
Antioxidant enzyme activity testing will be conducted at the Biomedical Laboratory, 
Faculty of Medicine, Padjadjaran University. Enzyme activity analysis will be performed 
on human blood serum collected on days 0 and 15. The analysis of antioxidant enzyme 
activity encompasses the assessment of superoxide dismutase (SOD), catalase (CAT) and 
glutathione peroxidase (GPx) activity. The analysis procedure will refer to the manual 
guideline in the Elabscience KIT. 
 
8. 
STATISTICAL ANALYSIS 
The mean data before and after treatment will be tested for homogeneity and normality. 
In order to draw parallels between the two data sets, parametric measurements will be 
considered using the T-test for data with normal distribution, while data with abnormal 
distribution will be analyzed using a non-parametric test, namely the Wilcoxon test. The 
statistical analysis of all data will be conducted using SPSS version 20.0. 
 
9. 
STORAGE OF FILES AND DATA 
9.1. Data Collections 
Paper-based CRFs (hard files) will be used to record data, with copies being made in the 
form of scanned files and stored in the researcher's personal Google Drive, with access 
restricted to the principal investigator. It is imperative that all CRFs are completed for 
each research subject. In order to reduce errors in filling out the forms and inconsistencies 
between the data in the CRF and the database, the data manager will validate the data as 
follows: by entering the numerical data twice into the database (double data entry), by 
rereading the comments written, or by entering the data once with 100% Quality Control 
(QC). In the event of any discrepancies, the resolution process will be initiated through 
the utilisation of a data clarification form, which must be signed by the researcher. It is 
imperative to note that the clarification sheet will be attached to the original CRF, thus 
serving as a crucial instrument for the rectification of any data that may be found to be 
inconsistent.  
 
9.2. Source Document 
Source documents encompass all clinical information, laboratory results (in their original 
form or as certified copies), observations or other clinical activities deemed necessary for 
the reconstruction and evaluation of clinical trials. It is imperative that all source 
documents are retained by the investigator. It is incumbent upon the investigator to ensure 
that auditors, ethics committees and other officials are permitted to view source 
documents when required. 
 
9.3. File Management in Clinical Trial Sites 
Researchers have an obligation to ensure that files are stored in accordance with GCP 
and ethical guidelines. 
 
9.4. Data and File Storage 

It is incumbent upon the principal investigators to retain research files and data for 
security purposes, as well as for the purposes of audit and inspection following the 
completion of the research. It is imperative that essential documents be retained for a 
period of no less than five years. 
 
10. 
QUALITY CONTROL AND ASSURANCE 
10.1. Procedures at the Research Site 
Standard Operating Procedures will be established for all relevant clinical and laboratory 
activities to ensure the quality of the research. Subject compliance will be monitored 
throughout the study to ensure adherence to the established inclusion and exclusion 
criteria. Researchers are obliged to sign and date all examination results, thereby 
confirming that said results have been reviewed. Researchers may appoint assistants to 
assist with the execution of research and the supervision of research assistants. 
Nevertheless, the onus for the research remains with the researcher. 
 
Prior to the initiation of the research process, ethical approval will be sought. Researchers 
must ensure that all personnel have been adequately briefed and trained on SA GCP, 
ICH-GCP, protocols and all procedures for research purposes. 
 
10.2. Research Supervision 
The principal investigator will be responsible for the validity of the data collected. The 
purpose of monitoring is threefold: firstly, to ensure that the human rights of research 
subjects are protected; secondly, to ensure that research data is accurate, complete and 
verifiable against source data; and thirdly, to ensure that clinical trials are conducted in 
compliance with protocols and do not violate the ethical principles as stated in the 
Declaration of Helsinki. 
 
The supervisor will inquire with the researcher about any missing or unclear data. All 
questions are to be addressed without delay. The supervision notes will document the 
findings during the supervision process, the reasons for the visit, and the signatures of 
the supervisor and research team.  
 
10.3. Management of Research Data 
The management of research data will adhere to rigorous protocols. All research data 
obtained will be entered into a screening form in hard copy format, which will then be 
meticulously compiled into a folder for each research subject. Subsequent to the entry of 
data, the screening form will undergo scanning on the same day and uploading to Google 
Drive as a soft copy, with the objective of minimising data loss. It is imperative to note 
that access to Google Drive is strictly limited to the primary research team, a measure 
that is crucial to ensure the strict confidentiality of the research data.  
 
10.4. Audit 
The audit process will be carried out by the principal investigator to assess compliance 
with the protocol, GCP guidelines and ethical principles. The objective of the audit is to 
evaluate the quality of data in terms of accuracy, adequacy and consistency, and to 
ascertain whether the research has been conducted in accordance with existing 
guidelines. As stipulated by Good Clinical Practice (GCP), a comprehensive review of 
all documentation pertaining to the research will be conducted as part of the audit. The 
audit will involve a comparison of the source documents with the CRF, with the objective 

of ensuring the accuracy and adequacy of the recorded information. This process will 
include the verification of any side effects that may have occurred.  
 
11. 
ETHICS AND RESPONSIBILITY 
11.1. Basic Principles 
This research will be conducted in accordance with the ethical principles set out in the 
Declaration of Helsinki.  
 
11.2. Independent Ethics Committee Assessment 
This research protocol will be reviewed by the Ethics Committee, which is an 
independent institution, and the Ethics Committee's assessment notes will be kept by the 
research team. Researchers will ensure the accuracy and completeness of the notes to be 
submitted to the Ethics Committee.  
 
11.3. Informed Consent 
Prior to the initiation of the study, written consent will be obtained from the subject, 
subsequent to the provision of a comprehensive explanation of the study.  
 
Prior to participation, the researcher will furnish the subject with comprehensive 
information regarding the study. Subsequent to the communication of salient information 
and the determination of the subject's comprehension of the explanation, the informed 
consent form can be endorsed by the subject, the researcher, and a witness.   
 
It is incumbent upon the researcher to ensure that each subject is provided with a full 
explanation of the research. The Ethics Committee must undertake a thorough evaluation 
of both the research participation consent form and information sheet, prior to their 
approval. 
 
The original informed consent form is retained in the CRF, with a copy being provided 
to the patient. An additional copy is maintained in the patient's medical records.  
 
Compensation for research subjects' expenses during the study: 
The researcher will assume financial responsibility for all costs associated with care, 
laboratory tests and medication. 
 
12. 
CONFIDENTIALITY 
The confidentiality of subjects involved in this study will be guaranteed by the research 
team and field doctors involved. Only the study number and initials will be written in the 
CRF. All correspondence related to subjects will use the study number and initials. The 
informed consent form will include a statement allowing the research team to view the 
source data for review purposes.  
 
13. 
PUBLICATION POLICY 
The results of this study are to be submitted for publication upon completion of the 
research, in the form of a joint publication with clinical researchers.  
 
14. 
IMPROVEMENT POLICY FOR PRODUCTIVITY 
It is imperative that any amendments to the protocol that occur during the research 
process are submitted in the form of protocol amendments and submitted to the Ethics 
Committee prior to implementation, particularly those that affect the safety, well-being, 

and comfort of research subjects. It is imperative that any such changes be subject to 
approval by both the researchers and the ethics committee. 
 
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APPENDIX 1. SCREENING FORM FOR SUBJECTS