UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036841
Receipt No. 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 2019/05/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email s_miyazaki@victorina-vc.jp

Sponsor
Institute Himeji Victorina Co., LTD
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 3HCTS Co., LTD
Address Ichigominamiikebukuro Bldg 2F, 2-27-27 Minamiikebukuro, Toshima-ku, Tokyo
Tel 03-6869-2920
Email 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
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 Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 24 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.