Effects of Tea Catechin Consumption on the Prophylaxis of... | NCT01008020

Studies
Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection

NCT01008020

Sponsor

Masahiro Morikawa

Status

Completed

Last Update Posted

Jul 16, 2013Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Influenza Infection

Interventions

tea catechin extracts

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Oct 29, 2009

First Submission Date that Met QC Criteria

Nov 3, 2009

First Posted Date

Nov 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2013

Last Update Posted Date

Jul 16, 2013Estimated

Name	Class
White Cross Nursing Home	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dietary supplement: placebo	No Intervention
Tea catechin extracts	Active Comparator		Dietary Supplement: tea catechin extracts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tea catechin extracts	Dietary Supplement	Tea catechin extracts 540 mg/day, are consumed for 5 months.	Tea catechin extracts

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroshi Yamada, MD, PhD	University of Shizuoka	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
White Cross Nursing Home		Higashimurayama	Tokyo	189-0021	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21338496	Derived	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.