UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024755 |
|---|---|
| Receipt number | R000028475 |
| Scientific Title | Effects of acidic milk on antioxidative activity in male collegiate Track&Field athlete |
| Date of disclosure of the study information | 2016/11/16 |
| Last modified on | 2016/11/08 14:34:19 |
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Basic information
Public title
Effects of acidic milk on antioxidative activity in male collegiate Track&Field athlete
Acronym
Effects of acidic milk on antioxidative activity in male collegiate Track&Field athlete
Scientific Title
Effects of acidic milk on antioxidative activity in male collegiate Track&Field athlete
Scientific Title:Acronym
Effects of acidic milk on antioxidative activity in male collegiate Track&Field athlete
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In male collegiate Track&Field athlete We compare the effects of antioxidative activity of acidic milk with isocalorically drinks after exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxidation stress (d-ROMs test)
Antioxidation power (BAP test)
Key secondary outcomes
Oxidative balance(BAP/d-ROMs),heartrate,feeling of fatigue
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
After exercise of acid milk (100kal,15.0g
protein,10.0g carbohydrate1,0.0g fat)
Interventions/Control_2
After exercise of isocalorically drinks (108kal,0.0g protein,26.7g carbohydrate1,0.0g fat)
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
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Subjects giving written informed consent
2)The male college student who belongs to the Track&Field athletics clubs
Key exclusion criteria
1)Seriously or progressive ill patients
2)Patients with milk or soy allergies
3)The person who has a diseases and is taling medicine at present
4)Person with smoking habit
5)The person who participates in other clinical tests
6)Subjects who were judged as unsuitable for this study by the principal investigator or the doctor for other reasons
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Uenisihi |
Organization
Kagawa Nutrition University
Division name
Physiological Nutrition
Zip code
Address
3-9-21,Chiyoda,Sakado,Saitama350-0288 japan
TEL
+81-49-284-3895
uenishi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Uenisihi |
Organization
Kagawa Nutrition University
Division name
Physiological Nutrition
Zip code
Address
3-9-21,Chiyoda,Sakado,Saitama350-0288,Japan
TEL
+81-49-284-3895
Homepage URL
uenishi@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition 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
| 2016 | Year | 11 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | 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
| 2016 | Year | 11 | Month | 08 | Day |
Last modified on
| 2016 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028475
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
