NCT06357273

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 4, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

White teaObesityWeight lossAppetite hormonesInflammationLipid profile

Outcome Measures

Primary Outcomes (3)

  • Weight loss

    Decrease in body weight

    3 months

  • Waist Circumference

    Decrease in waist circumference

    3 months

  • Body Mass Index

    Decrease in body mass index

    3 months

Secondary Outcomes (4)

  • Tumor Necrosis Factor - alpha

    3 months

  • Total cholesterol

    3 months

  • Low-Density Lipoprotein cholesterol

    3 months

  • High-Density Lipoprotein cholesterol

    3 months

Study Arms (4)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Obese individuals who applied to the Endocrinology and Metabolism outpatient clinic of tertiary hospital.

You may qualify if:

  • Body Mass Index of 30 and above (kg/m²)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University

Rize, 53100, Turkey (Türkiye)

Location

Related 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.

    PMID: 30336572BACKGROUND
  • 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.

    PMID: 33729498BACKGROUND
  • 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.

    PMID: 33058206BACKGROUND
  • 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.

    PMID: 26577614BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples obtained from routine laboratory investigations were retrieved (10 mL). Serum glucose, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride were determined with an autoanalyzer. Human-specific ELISA kits were used to measure leptin, adiponectin, ghrelin, asprosin, tumor necrosis factor alpha, interleukin- 6, interleukin-1β, matrix metallopeptidase-9, pancreatic lipase and 8-hydroxy-2' -deoxyguanosine. Serum malondialdehyde and glutathione levels were measured.

MeSH Terms

Conditions

ObesityWeight LossInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesPathologic Processes

Study Officials

  • Adnan Yılmaz, Prof.

    Recep Tayyip Erdogan University Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

July 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 15, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Sharing of individual participant data is prohibited by the Ethics committee. It is allowed on an individual basis.

Locations