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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024755
Receipt No. 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

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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
Email 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
Email uenishi@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition 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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028475

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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