Effects of Green Tea on Level of Serum Uric Acid in Healthy Individuals
Primary Purpose
Hyperuricemia, Gout
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
green tea extracts 2 gm/day
green tea extracts 4 gm/day
green tea extracts 6 gm/day
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia focused on measuring hyperuricemia, gout, uric acid, xanthine oxidase inhibitor, green tea, catechins, antioxidant
Eligibility Criteria
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
Sites / Locations
- Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Green tea extracts 2 gm/day
Green tea extracts 4 gm/day
Green tea extracts 6 gm/day
Arm Description
Green tea extracts 2 gm/day for 14 days
Green tea extracts 4 gm/day for 14 days
Green tea extracts 6 gm/day for 14 days
Outcomes
Primary Outcome Measures
serum uric acid
Secondary Outcome Measures
urinary uric acid excretion
serum antioxidant activity
serum EGCG level
Measurements of serum level of epigallocatechin gallate (EGCG)
Adverse events
Adverse events during 4-week study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01363869
Brief Title
Effects of Green Tea on Level of Serum Uric Acid in Healthy Individuals
Official Title
Effects of Green Tea on Level of Serum Uric Acid in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Gout
Keywords
hyperuricemia, gout, uric acid, xanthine oxidase inhibitor, green tea, catechins, antioxidant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Green tea extracts 2 gm/day
Arm Type
Experimental
Arm Description
Green tea extracts 2 gm/day for 14 days
Arm Title
Green tea extracts 4 gm/day
Arm Type
Experimental
Arm Description
Green tea extracts 4 gm/day for 14 days
Arm Title
Green tea extracts 6 gm/day
Arm Type
Experimental
Arm Description
Green tea extracts 6 gm/day for 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
green tea extracts 2 gm/day
Intervention Description
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
Intervention Name(s)
green tea extracts 4 gm/day
Intervention Description
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
Intervention Name(s)
green tea extracts 6 gm/day
Intervention Description
Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.
Total dosage is 6 grams per day.
Primary Outcome Measure Information:
Title
serum uric acid
Time Frame
4 weeks (prior to, immediately after and 7 days after intervention)
Secondary Outcome Measure Information:
Title
urinary uric acid excretion
Time Frame
4 weeks (prior to, immediately after and 7 days after intervention)
Title
serum antioxidant activity
Time Frame
4 weeks (prior to, immediately after and 7 days after intervention)
Title
serum EGCG level
Description
Measurements of serum level of epigallocatechin gallate (EGCG)
Time Frame
1 week (immediately after and 7 days after intervention)
Title
Adverse events
Description
Adverse events during 4-week study
Time Frame
4 week (prior to, immediately after and 7 days after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanon Jatuworapruk, M.D
Organizational Affiliation
Department of Internal medicine, Faculty of Medicine, Chiang Mai University, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
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Effects of Green Tea on Level of Serum Uric Acid in Healthy Individuals
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