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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06357273
Other study ID # WhiteTeaAY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date December 15, 2023

Study information

Verified date April 2024
Source Recep Tayyip Erdogan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date December 15, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Body Mass Index of 30 and above (kg/m²) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Weight loss Decrease in body weight 3 months
Primary Waist Circumference Decrease in waist circumference 3 months
Primary Body Mass Index Decrease in body mass index 3 months
Secondary Tumor Necrosis Factor - alpha Decrease in serum Tumor Necrosis Factor - alpha level 3 months
Secondary Total cholesterol Decrease in serum total cholesterol level 3 months
Secondary Low-Density Lipoprotein cholesterol Decrease in serum Low-Density Lipoprotein cholesterol level 3 months
Secondary High-Density Lipoprotein cholesterol Increase in serum High-Density Lipoprotein cholesterol level 3 months
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