UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of milk protein drink on appetite and appetite-related blood components
Title of the study (Brief title)	The effects of milk protein drink on appetite and appetite-related blood components
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the effect of milk protein drink or acidic milk protein drink on appetite and appetite-related components
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Food intake 2)Energy intake 3)Nutrition intake
Key secondary outcomes	1)Blood parameter regarding appetite 2)Subjective hunger score by visual analog scale(VAS) 3)Appetite-related protein profiling by proteomic analysis 4)Appetite-related circulating microRNAs profiling by microarray

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of milk protein drink-> Washout more than 2days-> Single ingestion of acidic milk protein drink-> Washout more than 2days-> Single ingestion of carbohydrate drink
Interventions/Control_2	Single ingestion of milk protein drink-> Washout more than 2days-> Single ingestion of carbohydrate drink -> Washout more than 2days-> Single ingestion of acidic milk protein drink
Interventions/Control_3	Single ingestion of acidic milk protein drink-> Washout more than 2days-> Single ingestion of milk protein drink-> Washout more than 2days-> Single ingestion of carbohydrate drink
Interventions/Control_4	Single ingestion of acidic milk protein drink-> Washout more than 2days-> Single ingestion of carbohydrate drink-> Washout more than 2days-> Single ingestion of milk protein drink
Interventions/Control_5	Single ingestion of carbohydrate drink -> Washout more than 2days-> Single ingestion of milk protein drink-> Washout more than 2days-> Single ingestion of acidic milk protein drink
Interventions/Control_6	Single ingestion of carbohydrate drink-> Washout more than 2days-> Single ingestion of acidic milk protein drink-> Washout more than 2days-> Single ingestion of milk protein drink
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	1)Subjects who have given written informed consent 2)Healthy males aged 20 to 30 years old
Key exclusion criteria	1)Subjects who have been regularly taking drugs, quasi drugs, health foods or supplements that may affect this study within a month prior to the start of this study 2)Subjects who are treated for diabetes 3)Subjects with serious or progressive illnesses 4)Subjects with food allergies 5)Subjects who are judged as ineligible for the study by the lead principal investigator for other reasons
Target sample size	20

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	077-561-5229
Email	safujita@fc.ritsumei.ac.jp

Public contact
Name of contact person	Teruyuki Noma
Organization	Meiji Co., Ltd
Division name	Health Science Research Department Food Science & Technology Research Laboratories R&D Division
Address	1-29-1, Nanakuni, Hachiouji, Tokyo 192-0919, Japan
TEL	042-632-5849
Homepage URL
Email	teruyuki.noma@meiji.com

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	立命館大学（滋賀県）/Ritsumeikan university(Shiga)

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 02 Month 08 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	2017 Year 02 Month 07 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029921