Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection

Influenza Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008020
• Other study ID #: CT2009002
• Status: Completed
• Phase: N/A
• First received: October 29, 2009
• Last updated: July 14, 2013
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: July 2013
• Source: University of Shizuoka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza Infection
• Influenza, Human

Intervention

Dietary Supplement:
• tea catechin extracts
Tea catechin extracts 540 mg/day, are consumed for 5 months.

Locations

Country	Name	City	State
Japan	White Cross Nursing Home	Higashi Murayama	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Masahiro Morikawa	White Cross Nursing Home

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence rates of influenza infection		Until 5 months consumption of the study capsules	No
Secondary	the incidence rates of upper respiratory tract infections		Until 5 months consumption of the study capsules	No
Secondary	the severity of the symptoms and the duration of the cold among incident cases		Until 5 months consumption of the study capsules	No
Secondary	occurrence of the adverse events		Until 5 months consumption of the study capsules	Yes