UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033278 |
|---|---|
| Receipt number | 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 14:05:01 |
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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
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
info@victorina-vc.jp
Sponsor or person
Institute
Himeji Victorina Co., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037941
