Effects of Green Tea on Level of Serum Uric Acid in Healthy Individuals

NCT ID: NCT01363869

Last Updated: 2013-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-03-31

Brief Summary

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Green tea has been extensively investigated for several potential health benefits. Previous studies have suggested that green tea may lower serum uric acid level in human. The purpose of this study is to investigate uric-lowering properties of green tea in healthy individuals.

Detailed Description

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Elevated serum uric acid is related to the risk of development of gout, the most common inflammatory arthritis in men. Allopurinol, a xanthine oxidase inhibitor, is one of the uric-lowering agents commonly used in patients suffering from recurrent and chronic gout. Nevertheless, its use is limited by adverse effects and serious allergic reaction in some patients.

Green tea is one of the most frequently consumed beverages, particularly in Japan. Green tea contains high level of catechins, in which Epigallocatechin gallate (EGCG) is the most abundant compound among other types of catechins. Antioxidant effect contributes to various potential health benefits of green tea. Several in-vitro studies have found that green tea inhibits xanthine oxidase activity and subsequently decreases reactive oxygen species (ROS) and uric acid production. We therefore would like to investigate the hypouricemic effects of green tea.

The study consists of three periods with a total duration of four weeks. The first week is the control period. The following two weeks is the interventional period and the last week is the follow up period. Thirty healthy participants will be randomly assigned into three experimental groups, receiving 2 gm/day, 4 gm/day and 6 gm/day (in capsule, two times after meal) of green tea extract during interventional period. Blood and urine samples will be taken at the beginning and at the end of each study period.

Conditions

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Hyperuricemia Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Green tea extracts 2 gm/day

Green tea extracts 2 gm/day for 14 days

Group Type EXPERIMENTAL

green tea extracts 2 gm/day

Intervention Type DIETARY_SUPPLEMENT

Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.

Total dosage is 2 grams per day.

Green tea extracts 4 gm/day

Green tea extracts 4 gm/day for 14 days

Group Type EXPERIMENTAL

green tea extracts 4 gm/day

Intervention Type DIETARY_SUPPLEMENT

Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.

Total dosage is 4 grams per day.

Green tea extracts 6 gm/day

Green tea extracts 6 gm/day for 14 days

Group Type EXPERIMENTAL

green tea extracts 6 gm/day

Intervention Type DIETARY_SUPPLEMENT

Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.

Total dosage is 6 grams per day.

Interventions

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green tea extracts 2 gm/day

Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.

Total dosage is 2 grams per day.

Intervention Type DIETARY_SUPPLEMENT

green tea extracts 4 gm/day

Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.

Total dosage is 4 grams per day.

Intervention Type DIETARY_SUPPLEMENT

green tea extracts 6 gm/day

Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.

Total dosage is 6 grams per day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Healthy individuals
* Normal renal and liver function from blood tests

Exclusion Criteria

* Presence of co-morbidity or currently ill
* Currently using any medication or nutritional supplement product that may affect serum uric acid level
* Serum creatinine higher than 1.5 mg/dl
* Abnormal serum Aspartate aminotransferase (AST) and/or Alanine transaminase (ALT)
* Greater than 15% change in serum uric acid during control period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Kanon Jatuworapruk

Kanon Jatuworapruk M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kanon Jatuworapruk, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Internal medicine, Faculty of Medicine, Chiang Mai University, Thailand

Locations

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Department of Internal Medicine, Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiang Mai, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MED-11-02-07-13-X

Identifier Type: -

Identifier Source: org_study_id

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