UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023154 |
|---|---|
| Receipt number | R000026638 |
| Scientific Title | Clinical effect of intake of yogurt on body condition in summer |
| Date of disclosure of the study information | 2017/02/09 |
| Last modified on | 2017/05/26 15:24:29 |
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Basic information
Public title
Clinical effect of intake of yogurt on body condition in summer
Acronym
Yogurt intervention study
Scientific Title
Clinical effect of intake of yogurt on body condition in summer
Scientific Title:Acronym
Yogurt intervention study
Region
| Japan |
Condition
Condition
N/A(healthy subjects)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the improvement effects of intake of yogurt on stress
or body condition in summer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire about stress and body condition
Key secondary outcomes
Biomarker about stress and body condition
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Yogurt (once a day for 12 weeks)
Interventions/Control_2
non treatment
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Subjects giving written informed consent
2)Healthy Japanese over 21 years of age
3)Workers over three days and 40 hours per week
4)Subjects who have a BMI < 35 kg/m2
Key exclusion criteria
1)Subjects who administer medications or go to hospital
regularly
2)Subjects who have a history of serious disease
3)Subjects with a compromised immune system
4)Subjects who have a history of malignancy
5)Subjects who habitually consume yogurt or fermented milk
products more than three times a week within two weeks of
prior to participate this study
6)Subjects have a history of allergy to food or medicine
7)Subjects who are pregnant or expected to be pregnant, or
lactating during the study
8)Subjects who participate in clinical trials within the last one
month prior to this study, or intend to participate in other
clinical trials after consent of this study
9)Subjects who are judged as unsuitable for the study by the
investigator for other reason
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Munenori Fukui |
Organization
Meiji Co., Ltd
Division name
Research & Development
Zip code
Address
540 Naruda, Odawara, Kanagawa, 250-0862, Japan
TEL
0465-37-3661
munenori.fukui@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Dairiki |
Organization
Meiji Co.,Ltd
Division name
Research & Development
Zip code
Address
540 Naruda, Odawara, Kanagawa, 250-0862, Japan
TEL
0465-37-3661
Homepage URL
kazuo.dairiki@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd
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
| 2017 | Year | 02 | Month | 09 | 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 | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 08 | 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 | 07 | Month | 13 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026638
