Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection

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

Detailed Description
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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.

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

Conditions
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Influenza Infection

Intervention / Treatment
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* Dietary Supplement: tea catechin extracts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Dietary supplement: placebo<br> | |
| Active Comparator: Tea catechin extracts<br> | Dietary Supplement: tea catechin extracts<br>* Tea catechin extracts 540 mg/day, are consumed for 5 months.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 
| occurrence of the adverse events |  | Until 5 months consumption of the study capsules | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tea catechin extracts, influenza infection, prophylaxis, supplements, adults over 20 years old, both men and women