UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory before-after study to evaluate the efficacy of dietary supplement ingestion on changes in body composition
Title of the study (Brief title)	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	Akira Hashimoto
Organization	Himeji Victorina Co., LTD.
Division name	President
Address	43-Chome, Shimoteramati, Himeji-City, Hyogo-Pref.
TEL	079-278-2023
Email	info@victorina-vc.jp

Public contact
Name of contact person	Satomi Miyazaki
Organization	Himeji Victorina Co., LTD.
Division name	none
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000037941