Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection

NCT ID: NCT01008020

Last Updated: 2013-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dietary supplement: placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Tea catechin extracts

Group Type ACTIVE_COMPARATOR

tea catechin extracts

Intervention Type DIETARY_SUPPLEMENT

Tea catechin extracts 540 mg/day, are consumed for 5 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tea catechin extracts

Tea catechin extracts 540 mg/day, are consumed for 5 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

White Cross Nursing Home

OTHER

Sponsor Role collaborator

Masahiro Morikawa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Masahiro Morikawa

Clinical Trials management office

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hiroshi Yamada, MD, PhD

Role: STUDY_CHAIR

University of Shizuoka

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

White Cross Nursing Home

Higashimurayama, Tokyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21338496 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CT2009002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Immunologic Effects of Echinacea
NCT00860795 COMPLETED NA