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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023154
Receipt No. 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

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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
Email 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
Email kazuo.dairiki@meiji.com

Sponsor
Institute Meiji Co., Ltd
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026638

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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