Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection

July 14, 2013 updated by: Masahiro Morikawa

A Randomized Controlled Study on the Effects of Tea Catechin Consumption on the Prevention of Influenza Infection in Healthy Adults

The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Higashi Murayama, Tokyo, Japan, 189-0021
        • White Cross Nursing Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Dietary supplement: placebo
Active Comparator: Tea catechin extracts
Dietary supplement: tea catechin extracts
Tea catechin extracts 540 mg/day, are consumed for 5 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence rates of influenza infection
Time Frame: Until 5 months consumption of the study capsules
Until 5 months consumption of the study capsules

Secondary Outcome Measures

Outcome Measure
Time Frame
the incidence rates of upper respiratory tract infections
Time Frame: Until 5 months consumption of the study capsules
Until 5 months consumption of the study capsules
the severity of the symptoms and the duration of the cold among incident cases
Time Frame: Until 5 months consumption of the study capsules
Until 5 months consumption of the study capsules
occurrence of the adverse events
Time Frame: Until 5 months consumption of the study capsules
Until 5 months consumption of the study capsules

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masahiro Morikawa

Collaborators

White Cross Nursing Home

Investigators

  • Study Chair: Hiroshi Yamada, MD, PhD, University of Shizuoka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 5, 2009

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 14, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT2009002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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