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Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01008020
First Posted: November 5, 2009
Last Update Posted: July 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
White Cross Nursing Home
Information provided by (Responsible Party):
Masahiro Morikawa, University of Shizuoka
  Purpose
The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.

Condition Intervention
Influenza Infection Dietary Supplement: tea catechin extracts

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Study on the Effects of Tea Catechin Consumption on the Prevention of Influenza Infection in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Masahiro Morikawa, University of Shizuoka:

Primary Outcome Measures:
  • the incidence rates of influenza infection [ Time Frame: Until 5 months consumption of the study capsules ]

Secondary Outcome Measures:
  • the incidence rates of upper respiratory tract infections [ Time Frame: 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 ]
  • occurrence of the adverse events [ Time Frame: Until 5 months consumption of the study capsules ]

Estimated Enrollment: 200
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008020


Locations
Japan
White Cross Nursing Home
Higashi Murayama, Tokyo, Japan, 189-0021
Sponsors and Collaborators
Masahiro Morikawa
White Cross Nursing Home
Investigators
Study Chair: Hiroshi Yamada, MD, PhD University of Shizuoka
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Masahiro Morikawa, Clinical Trials management office, University of Shizuoka
ClinicalTrials.gov Identifier: NCT01008020     History of Changes
Other Study ID Numbers: CT2009002
First Submitted: October 29, 2009
First Posted: November 5, 2009
Last Update Posted: July 16, 2013
Last Verified: July 2013

Keywords provided by Masahiro Morikawa, University of Shizuoka:
tea catechin extracts
influenza infection
prophylaxis
supplements
adults over 20 years old
both men and women

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents