NCT01363869

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

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

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

First Submitted

Initial submission to the registry

May 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 25, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

May 31, 2011

Last Update Submit

April 23, 2013

Conditions

Keywords

hyperuricemiagouturic acidxanthine oxidase inhibitorgreen teacatechinsantioxidant

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

EXPERIMENTAL

Green tea extracts 2 gm/day for 14 days

Dietary Supplement: green tea extracts 2 gm/day

Green tea extracts 4 gm/day

EXPERIMENTAL

Green tea extracts 4 gm/day for 14 days

Dietary Supplement: green tea extracts 4 gm/day

Green tea extracts 6 gm/day

EXPERIMENTAL

Green tea extracts 6 gm/day for 14 days

Dietary Supplement: green tea extracts 6 gm/day

Interventions

green tea extracts 2 gm/dayDIETARY_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 2 gm/day
green tea extracts 4 gm/dayDIETARY_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 4 gm/day
green tea extracts 6 gm/dayDIETARY_SUPPLEMENT

Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days. Total dosage is 6 grams per day.

Green tea extracts 6 gm/day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

HyperuricemiaGout

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kanon Jatuworapruk, M.D

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

    PRINCIPAL INVESTIGATOR

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

Locations