UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Estimation of effective intake of whey protein hydrolysate for stimulating muscle protein synthesis by using blood components as markers
Title of the study (Brief title)	Estimation of effective intake of whey protein hydrolysate for stimulating muscle protein synthesis
Region	Japan

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

Objectives
Narrative objectives1	To estimate the effective intake of whey protein hydrolysate for stimulating muscle protein synthesis by using blood components as markers
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma leucine concentration 0-120 min after ingestion of whey protein hydrolysate or essential amino acids
Key secondary outcomes	1)Plasma concentration of the following items 0-120 min after ingestion of whey protein hydrolysate or essential amino acids; essential amino acids, insulin, IGF-1 and 3-methyl-histidine 2)Blood glucose level 0-120 min after ingestion of whey protein hydrolysate or essential amino acids

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	They ingest the following foods one time in the following order more than six days apart; 7.5 g whey protein hydrolysate (WPH), 5.0 g WPH, 2.5 g WPH and 2.5 g essential amino acids
Interventions/Control_2	They ingest the following foods one time in the following order more than six days apart; 5.0 g whey protein hydrolysate (WPH), 2.5 g essential amino acids, 7.5 g WPH and 2.5 g WPH
Interventions/Control_3	They ingest the following foods one time in the following order more than six days apart; 2.5 g whey protein hydrolysate (WPH), 7.5 g WPH, 2.5 g essential amino acids and 5.0 g WPH
Interventions/Control_4	They ingest the following foods one time in the following order more than six days apart; 2.5 g essential amino acids, 2.5 g whey protein hydrolysate (WPH), 5.0 g WPH and 7.5 g WPH
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	Healthy men not less than 20 years old and under 30 years old
Key exclusion criteria	1) Seriously or progressive ill patients 2) Patients with liver or kidney dysfunction 3) Patients with food allergies 4) Patients with congenital aminoacidopathy 5) HBsAg or HCVAb positive patients 6) Persons who donated blood within 3 months
Target sample size	12

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	CPCC Co., Ltd.
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	チヨダパラメディカルケアクリニック

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 18 Day
Anticipated trial start date	2016 Year 02 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 06 Month 23 Day
Date analysis concluded	2016 Year 07 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 19 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024313