Influenza InfectionNCT01008020
Effects of Tea Catechin Consumption on the Prophylaxis of Influenza Infection
A study testing tea catechin extracts in people with Influenza Infection, run by Masahiro Morikawa at 1 site in Japan.
Trial summary
The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Infection
- What is being tested?
- tea catechin extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study on the Effects of Tea Catechin Consumption on the Prevention of Influenza Infection in Healthy Adults
The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.
Read the 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.
- Conditions
- Influenza Infection
- Being tested
- tea catechin extracts
- Keywords
- tea catechin extracts, influenza infection, prophylaxis, supplements, adults over 20 years old, both men and women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tea catechin extractsDietary supplement
Tea catechin extracts 540 mg/day, are consumed for 5 months.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement: placebo | No intervention | Not described |
| Tea catechin extracts | Active comparator | Not described Receives: Dietary Supplement: tea catechin extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rates of influenza infection
Measured: Until 5 months consumption of the study capsules
Secondary outcomes (3)
the incidence rates of upper respiratory tract infections
Measured: Until 5 months consumption of the study capsules
the severity of the symptoms and the duration of the cold among incident cases
Measured: Until 5 months consumption of the study capsules
occurrence of the adverse events
Measured: Until 5 months consumption of the study capsules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masahiro Morikawa
- Sponsor type
- University, hospital or other
- Collaborators
- White Cross Nursing Home
- Responsible party
- Sponsor-investigator, Masahiro Morikawa, University of Shizuoka
- Investigators
- Hiroshi Yamada, MD, PhD, Study chair, University of Shizuoka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008020
- Sponsor's protocol ID
- CT2009002
- Status last verified
- Jul 2013
- First submitted
- 29 Oct 2009
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21338496
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Effects of Tea Catechin Consumption on the Prevention of Influenza Infection in Healthy Adults
- ClinicalTrials.gov ID
- NCT01008020
- Acronym / sponsor ID
- CT2009002
- Conditions
- Influenza Infection
- Keywords
- tea catechin extracts, influenza infection, prophylaxis, supplements, adults over 20 years old, both men and women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Masahiro MorikawaUniversity, hospital or other
- Collaborators
- White Cross Nursing Home
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement: placebo | No intervention | – |
| Tea catechin extracts | Active comparator | Dietary Supplement: tea catechin extracts |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tea catechin extractsTea catechin extracts 540 mg/day, are consumed for 5 months. | Dietary supplement | Tea catechin extracts |
Primary outcome
the incidence rates of influenza infection
Time frame: Until 5 months consumption of the study capsules
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
- Derived from this study: PubMed 21338496Matsumoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Yamada, MD, PhD study chair
University of Shizuoka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tea catechin extracts in people with Influenza Infection, run by Masahiro Morikawa at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence rates of influenza infection (time frame: Until 5 months consumption of the study capsules). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01008020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.