UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of acidic milk on antioxidative activity in male collegiate Track&Field athlete
Title of the study (Brief title)	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	Kazuhiro Uenisihi
Organization	Kagawa Nutrition University
Division name	Physiological Nutrition
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	Kazuhiro Uenisihi
Organization	Kagawa Nutrition University
Division name	Physiological Nutrition
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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