- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06357273
The Effect of White Tea Consumption on Obesity
White Tea Consumption Alleviates on Body Composition, Oxidative Stress, Appetite Hormones, Inflammation and Lipids in Obese Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Rize, Turkey, 53100
- Recep Tayyip Erdogan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss
Time Frame: 3 months
|
Decrease in body weight
|
3 months
|
|
Waist Circumference
Time Frame: 3 months
|
Decrease in waist circumference
|
3 months
|
|
Body Mass Index
Time Frame: 3 months
|
Decrease in body mass index
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tumor Necrosis Factor - alpha
Time Frame: 3 months
|
Decrease in serum Tumor Necrosis Factor - alpha level
|
3 months
|
|
Total cholesterol
Time Frame: 3 months
|
Decrease in serum total cholesterol level
|
3 months
|
|
Low-Density Lipoprotein cholesterol
Time Frame: 3 months
|
Decrease in serum Low-Density Lipoprotein cholesterol level
|
3 months
|
|
High-Density Lipoprotein cholesterol
Time Frame: 3 months
|
Increase in serum High-Density Lipoprotein cholesterol level
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Adnan Yılmaz, Prof., Recep Tayyip Erdogan University Medical Faculty
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WhiteTeaAY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly