UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019465 |
|---|---|
| Receipt number | R000022509 |
| Scientific Title | Effect of ingestion of newly designed acid milk on plasma amino acids |
| Date of disclosure of the study information | 2015/10/23 |
| Last modified on | 2016/08/19 17:48:08 |
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Basic information
Public title
Effect of ingestion of newly designed acid milk on plasma amino acids
Acronym
Effect of ingestion of newly designed acid milk on plasma amino acids
Scientific Title
Effect of ingestion of newly designed acid milk on plasma amino acids
Scientific Title:Acronym
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
| 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
+81-77-561-5229
safujita@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 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
+81-77-561-5229
Homepage URL
safujita@fc.ritsumei.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 23 | 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
| 2015 | Year | 06 | Month | 17 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022509
