UMIN-CTR Clinical Trial

Basic information
Public title	The preventive effects of exercise + milk product intake on life-style related diseases and heat illness
Acronym	The effects of exercise + milk product intake
Scientific Title	The preventive effects of exercise + milk product intake on life-style related diseases and heat illness
Scientific Title:Acronym	The effects of exercise + milk product intake
Region	Japan

Condition
Condition	life style related diseases and heat illness
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We investigate the effects of exercise+product intake on the prevention of life-style related diseases and the improvement of body temperature regulation in the whole body and genetic levels.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The improvements of cardiovascular and blood glucose regulations
Key secondary outcomes	The improvements of body temperature, blood composition, and, physical activity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	glucose-electrolye solution
Interventions/Control_2	milk
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	50 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Those who have participated in the health promoton program in Matsumoto more than 6 month with >130mmHg of systolic or >85mmHg of diastolic blood pressures and >110mg/dl of fasting blood glucose concentration. 2) Those who can walk. 3) Those who show no allergy reaction to milk products. 4) Those who who participate in the study with their vouantary intention.
Key exclusion criteria	1) Those who cannnot walk. 2) Those who show allergy reaction to milk products. 3) Those who the investigator judge inappropriate.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroshi Nose
Organization	Shinshu University
Division name	Graduate School of Medicine
Zip code
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-2681
Email	nosehir@shinshu-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiroshi Nose
Organization	Shinshu University
Division name	Graduate School of Medicine
Zip code
Address	3-1-1 Asahi Matsumoto
TEL	0263-37-2681
Homepage URL
Email	nosehir@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	MECSST
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 04 Month 12 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
Date of protocol fixation	2016 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 12 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 04 Month 12 Day
Last modified on	2016 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025227

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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