UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ingestion of newly designed acid milk on plasma amino acids
Title of the study (Brief title)	Effect of ingestion of newly designed acid milk on plasma amino acids
Region	Japan

Condition
Condition	sarcopenia
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of ingestion of newly designed acid milk and skim milk on plasma amino acids
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma amino acids concentration 15-180 min after ingestion of newly designed acid milk or skim milk
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	They ingest newly designed acid milk(200 mL) one time, and then skim milk(200 mL) one time a week apart
Interventions/Control_2	They ingest skim milk(200 mL) one time, and then newly designed acid milk(200 mL) one time a week apart
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	Healthy men not less than 20 years old and under 30 years old
Key exclusion criteria	Constant users of supplements which contain protein or amino acids Diabetic patients Seriously or Progressive ill patients Food-allergic patients Lactose intolerance patients
Target sample size	10

Research contact person
Name of lead principal investigator	Satoshi Fujita
Organization	Ritsumeikan university
Division name	College of sports and health science
Address	1-1-1, Nojihigashi, Kusatsu-shi, Shiga 525-8577 Japan
TEL	+81-77-561-5229
Email	safujita@fc.ritsumei.ac.jp

Public contact
Name of contact person	Satoshi Fujita
Organization	Ritsumeikan university
Division name	College of sports and health science
Address	1-1-1, Nojihigashi, Kusatsu-shi, Shiga 525-8577 Japan
TEL	+81-77-561-5229
Homepage URL
Email	safujita@fc.ritsumei.ac.jp

Sponsor
Institute	Ritsumeikan university
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	2015 Year 10 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 17 Day
Anticipated trial start date	2015 Year 10 Month 23 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

Management information
Registered date	2015 Year 10 Month 22 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=R000022509