Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
A Randomized Controlled Study on the Effects of Tea Catechin Consumption on the Prevention of Influenza Infection in Healthy Adults
1 other identifier
interventional
200
1 country
1
Brief Summary
The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
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
October 29, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
November 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJuly 16, 2013
July 1, 2013
7 months
October 29, 2009
July 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence rates of influenza infection
Until 5 months consumption of the study capsules
Secondary Outcomes (3)
the incidence rates of upper respiratory tract infections
Until 5 months consumption of the study capsules
the severity of the symptoms and the duration of the cold among incident cases
Until 5 months consumption of the study capsules
occurrence of the adverse events
Until 5 months consumption of the study capsules
Study Arms (2)
Dietary supplement: placebo
NO INTERVENTIONTea catechin extracts
ACTIVE COMPARATORInterventions
Tea catechin extracts 540 mg/day, are consumed for 5 months.
Eligibility Criteria
You may qualify if:
- aged over 20 years
- possible to maintain without drinking tea more than 250 ml per day during the study
- possible to maintain without taking supplements or herbal products including catechin extracts during the study
- possible to fill out a questionnaire personally
- Obtained written informed consent before participation
You may not qualify if:
- Possessing some chronic infectious diseases in need of therapy
- Possessing tea or catechin allergy
- Possessing a history of influenza infection before six months prior to the study
- diagnosed as inadequate for other reasons to participate the study by principal investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Masahiro Morikawalead
- White Cross Nursing Homecollaborator
Study Sites (1)
White Cross Nursing Home
Higashimurayama, Tokyo, 189-0021, Japan
Related Publications (1)
Matsumoto K, Yamada H, Takuma N, Niino H, Sagesaka YM. Effects of green tea catechins and theanine on preventing influenza infection among healthcare workers: a randomized controlled trial. BMC Complement Altern Med. 2011 Feb 21;11:15. doi: 10.1186/1472-6882-11-15.
PMID: 21338496DERIVED
Study Officials
- STUDY CHAIR
Hiroshi Yamada, MD, PhD
University of Shizuoka
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Trials management office
Study Record Dates
First Submitted
October 29, 2009
First Posted
November 5, 2009
Study Start
November 1, 2009
Primary Completion
June 1, 2010
Study Completion
October 1, 2010
Last Updated
July 16, 2013
Record last verified: 2013-07