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Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection

This study has been completed.
Sponsor:
Collaborator:
White Cross Nursing Home
Information provided by:
University of Shizuoka
ClinicalTrials.gov Identifier:
NCT01008020
First received: October 29, 2009
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Cianidanol
U.S. FDA Resources

Further study details as provided by University of Shizuoka:

Primary Outcome Measures:
  • the incidence rates of influenza infection [ Time Frame: Until 5 months consumption of the study capsules ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the incidence rates of upper respiratory tract infections [ Time Frame: Until 5 months consumption of the study capsules ] [ Designated as safety issue: No ]
  • the severity of the symptoms and the duration of the cold among incident cases [ Time Frame: Until 5 months consumption of the study capsules ] [ Designated as safety issue: No ]
  • occurrence of the adverse events [ Time Frame: Until 5 months consumption of the study capsules ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008020

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

No publications provided by University of Shizuoka

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hiroshi Yamada/MD, PhD, University of Shizuoka
ClinicalTrials.gov Identifier: NCT01008020     History of Changes
Other Study ID Numbers: CT2009002
Study First Received: October 29, 2009
Last Updated: October 22, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013