UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041972