UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026032 |
|---|---|
| Receipt number | 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 13:42:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
teruyuki.noma@meiji.com
Sponsor or person
Institute
Ritsumeikan university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029921
