Effects of Green Tea on Level of Serum Uric Acid in Healthy Individuals
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 25, 2013
April 1, 2013
1.3 years
May 31, 2011
April 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum uric acid
4 weeks (prior to, immediately after and 7 days after intervention)
Secondary Outcomes (4)
urinary uric acid excretion
4 weeks (prior to, immediately after and 7 days after intervention)
serum antioxidant activity
4 weeks (prior to, immediately after and 7 days after intervention)
serum EGCG level
1 week (immediately after and 7 days after intervention)
Adverse events
4 week (prior to, immediately after and 7 days after intervention)
Study Arms (3)
Green tea extracts 2 gm/day
EXPERIMENTALGreen tea extracts 2 gm/day for 14 days
Green tea extracts 4 gm/day
EXPERIMENTALGreen tea extracts 4 gm/day for 14 days
Green tea extracts 6 gm/day
EXPERIMENTALGreen tea extracts 6 gm/day for 14 days
Interventions
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 capsule (1 gm per capsule), taken after meal, twice daily for 14 days. Total dosage is 4 grams per day.
Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days. Total dosage is 6 grams per day.
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Healthy individuals
- Normal renal and liver function from blood tests
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kanon Jatuworapruk, M.D
Department of Internal medicine, Faculty of Medicine, Chiang Mai University, Thailand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kanon Jatuworapruk M.D
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 2, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2012
Study Completion
March 1, 2013
Last Updated
April 25, 2013
Record last verified: 2013-04