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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026032
Receipt No. R000029921
Scientific Title The effects of milk protein drink on appetite and appetite-related blood components
Date of disclosure of the study information 2017/02/09
Last modified on 2018/03/29

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Basic information
Public title The effects of milk protein drink on appetite and appetite-related blood components
Acronym The effects of milk protein drink on appetite and appetite-related blood components
Scientific Title The effects of milk protein drink on appetite and appetite-related blood components
Scientific Title:Acronym 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
1st name
Middle name
Last name Satoshi Fujita
Organization Ritsumeikan university
Division name College of sports and health science
Zip code
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
1st name
Middle name
Last name Teruyuki Noma
Organization Meiji Co., Ltd
Division name Health Science Research Department Food Science & Technology Research Laboratories R&D Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 12 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000029921

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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