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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044173
Receipt No. R000050380
Scientific Title The single-arm before-after study of Greek yogurt on body composition, and subjective evaluation items
Date of disclosure of the study information 2021/05/17
Last modified on 2021/05/11

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Basic information
Public title The effects of Greek yogurt on body composition, and subjective evaluation items
Acronym The effects of Greek yogurt
Scientific Title The single-arm before-after study of Greek yogurt on body composition, and subjective evaluation items
Scientific Title:Acronym The before-after study of Greek yogurt
Region
Japan

Condition
Condition Healthy females
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of Greek yogurt on body composition, and subjective evaluation items
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body weight, Body Composition, Physical Function, and subjective evaluation items
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Subjects ingest one Greek yogurt daily for 12 weeks.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 20 or older female
Key exclusion criteria Milk-allergies
Subjects who use protein supplements habitually
Presence of chronic disease
Undergoing drug therapy or planning for drug therapy
Participation in another clinical study
Subjects who are assessed by the principal investigator to be unsuitable to participate in the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Kido
Organization Konan Women's University
Division name Faculty of Clinical Nutrition and Dietetics
Zip code 658-0001
Address 6-2-23, Morikita-machi, Higashinada-ku, Kobe-City, Hyogo-Pref
TEL 078-414-7134
Email kido@konan-wu.ac.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Kido
Organization Konan Women's University
Division name Faculty of Clinical Nutrition and Dietetics
Zip code 658-0001
Address 6-2-23, Morikita-machi, Higashinada-ku, Kobe-City, Hyogo-Pref
TEL 078-414-7134
Homepage URL
Email kido@konan-wu.ac.jp

Sponsor
Institute Konan Women's University
Institute
Department

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 Ethics committee of Konan Women's University
Address 6-2-23, Morikita-machi, Higashinada-ku, Kobe-City, Hyogo-Pref
Tel 078-414-7134
Email kido@konan-wu.ac.jp

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 甲南女子大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 17 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 17 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 11 Day
Last modified on
2021 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050380

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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