UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016083 |
|---|---|
| Receipt number | R000018322 |
| Scientific Title | The preventive efficacy against a cold and influenza by continuous consumption of yogurt containing lactoferrin. |
| Date of disclosure of the study information | 2014/12/29 |
| Last modified on | 2014/12/29 17:27:48 |
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Basic information
Public title
The preventive efficacy against a cold and influenza by continuous consumption of yogurt containing lactoferrin.
Acronym
LF Yogurt in Fukushima
Scientific Title
The preventive efficacy against a cold and influenza by continuous consumption of yogurt containing lactoferrin.
Scientific Title:Acronym
LF Yogurt in Fukushima
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of yogurt including Lactoferrin for prevention infective diseases such as cold and influenza, and to contribute to the development of effective health activities for employees.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Affected with infective diseases or not
Key secondary outcomes
SF-36, STAI (State-Trait Anxiety Inventory), The sense effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
In LF yogurt group, participants eat 1 cup of yogurt once a day including 100mg Lactoferrin for 16 weeks.
Interventions/Control_2
In control group, participants don't receive LF yogurt, and live with their usual lifestyles 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
Male and Female
Key inclusion criteria
(1)Employees of Fukushima prefecture companies.
(2)Those whose age at the time of informed consent is 20 and over.
(3)Those who can understand the purpose and the contents of this study, and can agree with participation by letter.
Key exclusion criteria
(1)The presence of allergic response to milk product.
(2)Those who have taken medical supplies or supplements which investigator judged that this trial would be affected.
(3)Those who are under treatment of severe disease such as cancer.
(4)Those who have excised the digestive organ.
(5)Pregnancy or beast-feeding.
(6)In addition, those who were judged inadequate by investigator.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Tanigawa |
Organization
Graduate School of Medicine, Ehime University
Division name
Department of Public Health
Zip code
Address
Shizukawa, Toon-city, Ehime
TEL
089-960-5283
tt9178tt9178@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Kinoshita |
Organization
Community Life Sciences Co., Ltd.
Division name
Social Epidemiology Institute
Zip code
Address
160-4 Kishimachi, Matsuyama-city, Ehime
TEL
089-904-7811
Homepage URL
tetsu.prospective@gmail.com
Sponsor or person
Institute
Department of Public Health, Graduate School of Medicine, Ehime University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
| 2014 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 15 | 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
| 2014 | Year | 12 | Month | 29 | Day |
Last modified on
| 2014 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018322
| Research Plan | |
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| 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 |
