UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023932 |
|---|---|
| Receipt number | R000027455 |
| Scientific Title | A study for investigating preventive effects of yogurt on the development of flulike symptoms |
| Date of disclosure of the study information | 2016/09/10 |
| Last modified on | 2018/05/23 10:20:39 |
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Basic information
Public title
A study for investigating preventive effects of yogurt on the development of flulike symptoms
Acronym
A study for investigating preventive effects of yogurt on the development of flulike symptoms
Scientific Title
A study for investigating preventive effects of yogurt on the development of flulike symptoms
Scientific Title:Acronym
A study for investigating preventive effects of yogurt on the development of flulike symptoms
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the influence of successive intake of yogurt on (1) prevention of the development of flulike symptoms, (2) immune responses and (3) health related quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative incidence of influenza
Key secondary outcomes
Symptoms of the common cold (incidence, frequency and severity)
Immunological tests using bloods
Health related quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of yogurt for 16 weeks
Interventions/Control_2
non-consumption of yogurt for 16 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Female subjects aged twenty or more
Licentiates working in medical institutes as health or welfare professional
(2) Subjects who can understand the purpose and the contents of this study, and can agree to participation in this study by letter
Key exclusion criteria
(1) Pregnant women
(2) Subjects who contracted influenza during the period of July 2016 to the date of giving written informed consent
(3) Subjects who show allergic responses to dairy products
(4) Lactose intolerant subjects
(5) Subjects who are instructed to restrict calories by physician
(6) Subjects with a history of diseases involving the immune system (e.g. rheumatism, cancer, thyroid disorder, systemic erythematodes, myasthenia gravis, graves disease, scleroderma )
(7) Subjects who have participated in other clinical tests within the past three months
(8) Subjects who were judged inadequate by investigator for other reasons
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Saito |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Basic Nursing and Health Science
Zip code
Address
454 Shizukawa, Toon, Ehime
TEL
089-964-5111
saitoi@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Social Epidemiology Institute
Zip code
Address
1383-2 hiraimachi, Matsuyama, Ehime
TEL
089-904-7811
Homepage URL
tetsu@shin-science.co.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 05 | Day |
Last modified on
| 2018 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027455
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
