Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
Primary Purpose
Influenza Infection
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
tea catechin extracts
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Infection focused on measuring tea catechin extracts, influenza infection, prophylaxis, supplements, adults over 20 years old, both men and women
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- White Cross Nursing Home
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Dietary supplement: placebo
Tea catechin extracts
Arm Description
Outcomes
Primary Outcome Measures
the incidence rates of influenza infection
Secondary Outcome Measures
the incidence rates of upper respiratory tract infections
the severity of the symptoms and the duration of the cold among incident cases
occurrence of the adverse events
Full Information
NCT ID
NCT01008020
First Posted
October 29, 2009
Last Updated
July 14, 2013
Sponsor
Masahiro Morikawa
Collaborators
White Cross Nursing Home
1. Study Identification
Unique Protocol Identification Number
NCT01008020
Brief Title
Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
Official Title
A Randomized Controlled Study on the Effects of Tea Catechin Consumption on the Prevention of Influenza Infection in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Masahiro Morikawa
Collaborators
White Cross Nursing Home
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.
Detailed Description
Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent experimental studies have revealed that tea catechin extracts prevent influenza infection, but few studies have been conducted on the clinical effects of tea catechin consumption on the prophylaxis of influenza infection. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of 5 months tea catechin consumption on the prophylaxis of influenza infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Infection
Keywords
tea catechin extracts, influenza infection, prophylaxis, supplements, adults over 20 years old, both men and women
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary supplement: placebo
Arm Type
No Intervention
Arm Title
Tea catechin extracts
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
tea catechin extracts
Intervention Description
Tea catechin extracts 540 mg/day, are consumed for 5 months.
Primary Outcome Measure Information:
Title
the incidence rates of influenza infection
Time Frame
Until 5 months consumption of the study capsules
Secondary Outcome Measure Information:
Title
the incidence rates of upper respiratory tract infections
Time Frame
Until 5 months consumption of the study capsules
Title
the severity of the symptoms and the duration of the cold among incident cases
Time Frame
Until 5 months consumption of the study capsules
Title
occurrence of the adverse events
Time Frame
Until 5 months consumption of the study capsules
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroshi Yamada, MD, PhD
Organizational Affiliation
University of Shizuoka
Official's Role
Study Chair
Facility Information:
Facility Name
White Cross Nursing Home
City
Higashi Murayama
State/Province
Tokyo
ZIP/Postal Code
189-0021
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21338496
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
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