UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036841 |
|---|---|
| Receipt number | R000041972 |
| Scientific Title | An exploratory study to evaluate the efficacy of milk protein ingestion on the physical sensation |
| Date of disclosure of the study information | 2019/05/27 |
| Last modified on | 2019/11/25 15:51:26 |
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Basic information
Public title
An exploratory study to evaluate the efficacy of milk protein ingestion on the physical sensation
Acronym
Effects of milk protein intake on physical sensation
Scientific Title
An exploratory study to evaluate the efficacy of milk protein ingestion on the physical sensation
Scientific Title:Acronym
Effects of milk protein intake on physical sensation
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effects of milk protein ingestion to athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective questionnaire evaluation, Autonomic nervous system, Sleep level, POMS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Protein powder beverage, 4 days
Interventions/Control_2
Placebo beverage, 4 days
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 High risk of 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
15
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Hashimoto |
Organization
Himeji Victorina Co., LTD.
Division name
President
Zip code
670-0932
Address
43-Chome, Shimoteramati, Himeji-City, Hyogo-Pref.
TEL
079-278-2023
s_miyazaki@victorina-vc.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Miyazaki |
Organization
Himeji Victorina Co., LTD.
Division name
Non
Zip code
670-0932
Address
43-Chome, Shimoteramati, Himeji-City, Hyogo-Pref.
TEL
079-278-2023
Homepage URL
s_miyazaki@victorina-vc.jp
Sponsor or person
Institute
Himeji Victorina Co., LTD
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
3HCTS Co., LTD
Address
Ichigominamiikebukuro Bldg 2F, 2-27-27 Minamiikebukuro, Toshima-ku, Tokyo
Tel
03-6869-2920
Non
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
| 2019 | Year | 05 | Month | 27 | 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
12
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
| 2019 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 06 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 24 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041972
