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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033278
Receipt No. R000037941
Scientific Title An exploratory before-after study to evaluate the efficacy of dietary supplement ingestion on changes in body composition
Date of disclosure of the study information 2018/07/11
Last modified on 2019/01/07

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Basic information
Public title An exploratory before-after study to evaluate the efficacy of dietary supplement ingestion on changes in body composition
Acronym Effects of dietary supplement intake on body composition
Scientific Title An exploratory before-after study to evaluate the efficacy of dietary supplement ingestion on changes in body composition
Scientific Title:Acronym Effects of dietary supplement intake on body composition
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effectiveness of ingesting dietary supplement ingestion to athletes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body composition
Key secondary outcomes Exercise performance

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Protein jelly beverage
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
40 years-old >
Gender Female
Key inclusion criteria 1) More than 20 years and less than 40 years old
2) Women's volleyball player belonging to the execution facility
Key exclusion criteria 1) Subjects with milk allergy and soybean allergy
2) Subjects who can not perform training
3) Subjects who are willing to become pregnant during the exam, pregnant, Breastfeeding
4) Subjects who are judged inappropriate for the study by the physician.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Hashimoto
Organization Himeji Victorina Co., LTD.
Division name President
Zip code
Address 43-Chome, Shimoteramati, Himeji-City, Hyogo-Pref.
TEL 079-278-2023
Email info@victorina-vc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Miyazaki
Organization Himeji Victorina Co., LTD.
Division name none
Zip code
Address 43-Chome, Shimoteramati, Himeji-City, Hyogo-Pref.
TEL 079-278-2023
Homepage URL
Email info@victorina-vc.jp

Sponsor
Institute Himeji Victorina Co., LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2018 Year 07 Month 11 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
2018 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 11 Day
Last follow-up date
2018 Year 10 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037941

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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