ObesityNCT06357273
The Effect of White Tea Consumption on Obesity
An observational study of Obesity and Obesity; Endocrine, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Obesity is an increasing global public health issue. In general, tea consumption have been shown to offer benefit to obese patients. However, the potential of white tea (WT) to treat and protect from the adverse effects of obesity have not been addressed so far. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Obesity; Endocrine, Obesity Adult Onset
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 15 Dec 2023
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese individuals who applied to the Endocrinology and Metabolism outpatient clinic of tertiary hospital.
Who may be able to join
- Body Mass Index of 30 and above (kg/m²)
Who cannot join
- smoking
- physical disability preventing participating in the exercise programs
- joint problem preventing participating in the exercise programs
- trauma preventing participating in the exercise programs
- malignancy
- history of cerebrovascular disease
- active use of antidepressant drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: White Tea Consumption Alleviates on Body Composition, Oxidative Stress, Appetite Hormones, Inflammation and Lipids in Obese Patients
Obesity is an increasing global public health issue. In general, tea consumption have been shown to offer benefit to obese patients. However, the potential of white tea (WT) to treat and protect from the adverse effects of obesity have not been addressed so far. The aim of this study was to examine the efficacy and impact WT consumption highest in catechins on levels of anthropometric and biochemical values in obese patients.
Read the detailed description
Obesity is the increase in body weight above the normal level as a result of excessive fat accumulation. This condition is a chronic metabolic disease that increases the risk of long-term medical complications. The prevalence of obesity is an increasing global public health problem. Numerous conditions such as excessive and malnutrition, lack of physical activity, hormonal factors, genetic and psychological factors, and medicine use are effective in the formation of obesity. Obesity is associated with many diseases such as cardiovascular diseases, type 2 diabetes, hypertension, and dyslipidemia.
Since the mechanical load and myocardial metabolism increase in obesity, oxygen consumption also increases. Therefore, there is an increase in the formation of oxygen radicals (ROS) caused by mitochondrial respiration. Oxidative stress and ROS stimulate pro-inflammatory cytokine release. ROS attack macromolecules such as DNA, proteins, lipids. Macromolecular damage results in cellular damage and death. Damages caused by ROS are repaired by antioxidant defense systems. It has been suggested that inflammatory markers such as ghrelin, leptin, adiponectin, interleukins, matrix metalloproteinases, tumor necrosis factor are associated with insulin resistance in obese patients. These substances are effective on food intake, energy balance, insulin activity, lipid and glucose metabolism, angiogenesis and vascular structuring and blood pressure in the body.
Many drugs have been used to treat obesity. Orlistat is a widely used drug to treat this disease. It reversibly inhibits gastric and pancreatic lipases. Inactivation of lipases prevents the hydrolysis of triglycerides. Metformin, a dimethylbiguanide, inhibits the mitochondrial complex-I, which leads to adenosine 5-monophosphate activated protein kinase (AMPK) activation. By affecting the AMPK level, it provides the translocation of the glucose transporter 4 protein independently of insulin and regulates the blood glucose level. Clinicians often prescribe it to achieve weight loss. However, they have evinced serious adverse effects, including headache, cardiovascular diseases and depression, which restrict their use.
In recent years, one of the fastest growing fields in the treatment of obesity is the use of natural herbal products and many studies have proven the use of herbal products to be effective and safe. Especially, tea is reported to have anti-obesity, anti-diabetes, anti-inflammatory and hypolipidaemic actions.
Tea is produced from the leaves of the Camellia sinensis plant, which belongs to the Theaceae family, and is one of the most consumed beverages after water in many societies. In general, four types of tea are produced from the tea plant. WT differs from other teas in that only the buds and young leaves of the plant are used. WT has important benefits for human health with its high content of catechins and derivatives, as well as other tea components.
In the literature searches, no clinical research has been found on the effect of WT on obesity, which is richer than other tea varieties in terms of antioxidant properties and produced with less processing. This study aimed to determine the effect of WT consumption on obesity and the relationship between anthropometric and biochemical values of WT consumption in obese individuals.
- Conditions
- Obesity, Obesity; Endocrine, Obesity Adult Onset
- Keywords
- White tea, Obesity, Weight loss, Appetite hormones, Inflammation, Lipid profile
- Medical subject headings
- Obesity, Weight Loss, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control (CONT) | Obese patients who did not receive any drugs or herbal supplement were offered to be included in the CONT group. | |
| Orlistat (ORL) | Obese patients who were treated with orlistat were offered to be included in the ORL group. | |
| Metformin (METF) | Obese patients who were treated with metformin were offered to be included in the METF group. | |
| White Tea (WT) | Obese patients who did not receive any drugs, but were taking white tea were offered to be included in the WT group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Decrease in body weight
Measured: 3 months
Waist Circumference
Decrease in waist circumference
Measured: 3 months
Body Mass Index
Decrease in body mass index
Measured: 3 months
Secondary outcomes (4)
Tumor Necrosis Factor - alpha
Decrease in serum Tumor Necrosis Factor - alpha level
Measured: 3 months
Total cholesterol
Decrease in serum total cholesterol level
Measured: 3 months
Low-Density Lipoprotein cholesterol
Decrease in serum Low-Density Lipoprotein cholesterol level
Measured: 3 months
High-Density Lipoprotein cholesterol
Increase in serum High-Density Lipoprotein cholesterol level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jul 2023
- Primary completion1 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerimali Akyıldız, Recep Tayyip Erdogan University
- Investigators
- Adnan Yılmaz, Prof., Study director, Recep Tayyip Erdogan University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357273
- Sponsor's protocol ID
- WhiteTeaAY
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of individual participant data is prohibited by the Ethics committee. It is allowed on an individual basis.
Publications
Castro-Barquero S, Lamuela-Raventos RM, Domenech M, Estruch R. Relationship between Mediterranean Dietary Polyphenol Intake and Obesity. Nutrients. 2018 Oct 17;10(10):1523. doi: 10.3390/nu10101523.
PubMed 30336572Taylor EB. The complex role of adipokines in obesity, inflammation, and autoimmunity. Clin Sci (Lond). 2021 Mar 26;135(6):731-752. doi: 10.1042/CS20200895.
PubMed 33729498Xia X, Lin Z, Shao K, Wang X, Xu J, Zhai H, Wang H, Xu W, Zhao Y. Combination of white tea and peppermint demonstrated synergistic antibacterial and anti-inflammatory activities. J Sci Food Agric. 2021 Apr;101(6):2500-2510. doi: 10.1002/jsfa.10876. Epub 2020 Oct 30.
PubMed 33058206Yang CS, Zhang J, Zhang L, Huang J, Wang Y. Mechanisms of body weight reduction and metabolic syndrome alleviation by tea. Mol Nutr Food Res. 2016 Jan;60(1):160-74. doi: 10.1002/mnfr.201500428. Epub 2015 Dec 9.
PubMed 26577614
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Tea Consumption Alleviates on Body Composition, Oxidative Stress, Appetite Hormones, Inflammation and Lipids in Obese Patients
- ClinicalTrials.gov ID
- NCT06357273
- Acronym / sponsor ID
- WhiteTeaAY
- Conditions
- Obesity, Obesity; Endocrine, Obesity Adult Onset
- Keywords
- White tea, Obesity, Weight loss, Appetite hormones, Inflammation, Lipid profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is an increasing global public health issue. In general, tea consumption have been shown to offer benefit to obese patients. However, the potential of white tea (WT) to treat and protect from the adverse effects of obesity have not been addressed so far. The aim of this study was to examine the efficacy and impact WT consumption highest in catechins on levels of anthropometric and biochemical values in obese patients.
Detailed description
Obesity is the increase in body weight above the normal level as a result of excessive fat accumulation. This condition is a chronic metabolic disease that increases the risk of long-term medical complications. The prevalence of obesity is an increasing global public health problem. Numerous conditions such as excessive and malnutrition, lack of physical activity, hormonal factors, genetic and psychological factors, and medicine use are effective in the formation of obesity. Obesity is associated with many diseases such as cardiovascular diseases, type 2 diabetes, hypertension, and dyslipidemia.
Since the mechanical load and myocardial metabolism increase in obesity, oxygen consumption also increases. Therefore, there is an increase in the formation of oxygen radicals (ROS) caused by mitochondrial respiration. Oxidative stress and ROS stimulate pro-inflammatory cytokine release. ROS attack macromolecules such as DNA, proteins, lipids. Macromolecular damage results in cellular damage and death. Damages caused by ROS are repaired by antioxidant defense systems. It has been suggested that inflammatory markers such as ghrelin, leptin, adiponectin, interleukins, matrix metalloproteinases, tumor necrosis factor are associated with insulin resistance in obese patients. These substances are effective on food intake, energy balance, insulin activity, lipid and glucose metabolism, angiogenesis and vascular structuring and blood pressure in the body.
Many drugs have been used to treat obesity. Orlistat is a widely used drug to treat this disease. It reversibly inhibits gastric and pancreatic lipases. Inactivation of lipases prevents the hydrolysis of triglycerides. Metformin, a dimethylbiguanide, inhibits the mitochondrial complex-I, which leads to adenosine 5-monophosphate activated protein kinase (AMPK) activation. By affecting the AMPK level, it provides the translocation of the glucose transporter 4 protein independently of insulin and regulates the blood glucose level. Clinicians often prescribe it to achieve weight loss. However, they have evinced serious adverse effects, including headache, cardiovascular diseases and depression, which restrict their use.
In recent years, one of the fastest growing fields in the treatment of obesity is the use of natural herbal products and many studies have proven the use of herbal products to be effective and safe. Especially, tea is reported to have anti-obesity, anti-diabetes, anti-inflammatory and hypolipidaemic actions.
Tea is produced from the leaves of the Camellia sinensis plant, which belongs to the Theaceae family, and is one of the most consumed beverages after water in many societies. In general, four types of tea are produced from the tea plant. WT differs from other teas in that only the buds and young leaves of the plant are used. WT has important benefits for human health with its high content of catechins and derivatives, as well as other tea components.
In the literature searches, no clinical research has been found on the effect of WT on obesity, which is richer than other tea varieties in terms of antioxidant properties and produced with less processing. This study aimed to determine the effect of WT consumption on obesity and the relationship between anthropometric and biochemical values of WT consumption in obese individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control (CONT) | – | –Obese patients who did not receive any drugs or herbal supplement were offered to be included in the CONT group. |
| Orlistat (ORL) | – | –Obese patients who were treated with orlistat were offered to be included in the ORL group. |
| Metformin (METF) | – | –Obese patients who were treated with metformin were offered to be included in the METF group. |
| White Tea (WT) | – | –Obese patients who did not receive any drugs, but were taking white tea were offered to be included in the WT group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese individuals who applied to the Endocrinology and Metabolism outpatient clinic of tertiary hospital.
Key inclusion criteria (1 listed)
- Body Mass Index of 30 and above (kg/m²)
Key exclusion criteria (7 listed)
- smoking
- physical disability preventing participating in the exercise programs
- joint problem preventing participating in the exercise programs
- trauma preventing participating in the exercise programs
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight loss
Time frame: 3 months
Decrease in body weight
Waist Circumference
Time frame: 3 months
Decrease in waist circumference
Body Mass Index
Time frame: 3 months
Decrease in body mass index
4 secondary outcomes
Tumor Necrosis Factor - alpha
Time frame: 3 months
Total cholesterol
Time frame: 3 months
Low-Density Lipoprotein cholesterol
Time frame: 3 months
High-Density Lipoprotein cholesterol
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 30336572Castro-Barquero S, Lamuela-Raventos RM, Domenech M, Estruch R. Relationship between Mediterranean Dietary Polyphenol Intake and Obesity. Nutrients. 2018 Oct 17;10(10):1523. doi: 10.3390/nu10101523.
- Background: PubMed 33729498Taylor EB. The complex role of adipokines in obesity, inflammation, and autoimmunity. Clin Sci (Lond). 2021 Mar 26;135(6):731-752. doi: 10.1042/CS20200895.
- Background: PubMed 33058206Xia X, Lin Z, Shao K, Wang X, Xu J, Zhai H, Wang H, Xu W, Zhao Y. Combination of white tea and peppermint demonstrated synergistic antibacterial and anti-inflammatory activities. J Sci Food Agric. 2021 Apr;101(6):2500-2510. doi: 10.1002/jsfa.10876. Epub 2020 Oct 30.
- Background: PubMed 26577614Yang CS, Zhang J, Zhang L, Huang J, Wang Y. Mechanisms of body weight reduction and metabolic syndrome alleviation by tea. Mol Nutr Food Res. 2016 Jan;60(1):160-74. doi: 10.1002/mnfr.201500428. Epub 2015 Dec 9.
- Individual participant dataSharing planned: No. Sharing of individual participant data is prohibited by the Ethics committee. It is allowed on an individual basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Yılmaz, Prof. study director
Recep Tayyip Erdogan University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity; Endocrine, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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 10 Apr 2024. 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 Turkey (Türkiye). 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?
Weight loss (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357273, which also lists 4 linked publications.
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 10 Apr 2024.