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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).

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

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.

Turkey (Türkiye)1 site
  • Recep Tayyip Erdogan University

    Rize, 53100

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06357273
Study groupRoleWhat 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.

  1. Weight loss

    Decrease in body weight

    Measured: 3 months

  2. Waist Circumference

    Decrease in waist circumference

    Measured: 3 months

  3. Body Mass Index

    Decrease in body mass index

    Measured: 3 months

Secondary outcomes (4)
  1. Tumor Necrosis Factor - alpha

    Decrease in serum Tumor Necrosis Factor - alpha level

    Measured: 3 months

  2. Total cholesterol

    Decrease in serum total cholesterol level

    Measured: 3 months

  3. Low-Density Lipoprotein cholesterol

    Decrease in serum Low-Density Lipoprotein cholesterol level

    Measured: 3 months

  4. 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.

  1. First posted10 Apr 2024
  2. Study start1 Jul 2023
  3. Primary completion1 Nov 2023
  4. Study completion15 Dec 2023

Resources

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)
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 30336572
  • Taylor 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 33729498
  • Xia 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 33058206
  • Yang 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

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.

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