UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Additional analysis of blood samples obtained from the study of single ingestion of whey protein hydrolysates (UMIN000021108)
Title of the study (Brief title)	Additional analysis of blood samples obtained from previous study
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze metabolites of blood samples after ingestion whey protein hydrolysates
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Metabolites in plasma (0, 10, 20, 60 min after ingestion of whey protein hydrolysates)
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	30 years-old >
Gender	Male
Key inclusion criteria	The subjects of previous study (UMIN000021108)
Key exclusion criteria	None
Target sample size	5

Research contact person
Name of lead principal investigator	Shuji Ikegami
Organization	Meiji Co., Ltd.
Division name	Sports Nutrition Research Department Food Science Research Laboratories R&D Division
Address	540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL	+81-465-37-3796
Email	shuuji.ikegami@meiji.com

Public contact
Name of contact person	Chiaki Sanbongi
Organization	Meiji Co., Ltd.
Division name	Sports Nutrition Research Department Food Science Research Laboratories R&D Division
Address	540 Naruda, Odawara, Kanagawa 250-0862, Japan
TEL	+81-465-37-3796
Homepage URL
Email	chiaki.sanbongi@meiji.com

Sponsor
Institute	Meiji Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 02 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 03 Day
Anticipated trial start date	2017 Year 02 Month 17 Day
Last follow-up date
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	To analyze metabolites in plasma obtained from pevious study (UMIN000021108)

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2017 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030068