UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012510 |
|---|---|
| Receipt number | R000014635 |
| Scientific Title | Health enhancement effects verification by continuous intake of a lactobacillus beverage |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2014/11/23 17:40:41 |
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Basic information
Public title
Health enhancement effects verification by continuous intake of a lactobacillus beverage
Acronym
"Calpis" communication project 2
Scientific Title
Health enhancement effects verification by continuous intake of a lactobacillus beverage
Scientific Title:Acronym
"Calpis" communication project 2
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the health enhancement effects for elders by continuous intake of lactobacillus beverage mainly to their QOL(Quality Of Life), mental health, and level of happiness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL Score (SF-8)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
First 8 weeks, participants spend the period as usual without drinking "Calpis".
Next 8 weeks, participants prepare 150ml "Calpis" per day by themselves and drink it.
The last 8 weeks, participants spend the period without drinking "Calpis". However, only those who have agreed anew participate in this period.
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who live in Kamijima-town, Ehime prefecture
(2) That whose age at the time of informed consent is aged 40 and over.
(3) Those who can understand the purpose and the contents of this study, and can agree with participation to this study by letter.
Key exclusion criteria
(1) Those who show an allergic reaction to dairy products and a soybean.
(2) The person under diabetes medical treatment, or those who need to treat diabetes.
(3) Those who have taken medical supplies or supplements which investigator judged that this trial would be affected.
(4) In addition, those who were judged inadequate by investigator.
Target sample size
120
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 SHIN Science 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
Calpis 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 | 10 | Month | 01 | 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
| 2013 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 09 | 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
| 2013 | Year | 12 | Month | 06 | Day |
Last modified on
| 2014 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014635
