UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044173 |
|---|---|
| Receipt number | 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 13:38:26 |
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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
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
kido@konan-wu.ac.jp
Sponsor or person
Institute
Konan Women's 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
Ethics committee of Konan Women's University
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe-City, Hyogo-Pref
Tel
078-414-7134
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050380
