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Completed

NCT Number: NCT01363869

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chiang Mai, 50200, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

green tea extracts 2 gm/day

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

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

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.

Primary outcomes

  1. serum uric acid

    Time frame: 4 weeks (prior to, immediately after and 7 days after intervention)

Secondary outcomes

  1. urinary uric acid excretion

    Time frame: 4 weeks (prior to, immediately after and 7 days after intervention)

  2. serum antioxidant activity

    Time frame: 4 weeks (prior to, immediately after and 7 days after intervention)

  3. serum EGCG level

    Time frame: 1 week (immediately after and 7 days after intervention)

    Measurements of serum level of epigallocatechin gallate (EGCG)

  4. Adverse events

    Time frame: 4 week (prior to, immediately after and 7 days after intervention)

    Adverse events during 4-week study

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 2, 2011
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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