UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021879
Receipt No. R000025227
Scientific Title The preventive effects of exercise + milk product intake on life-style related diseases and heat illness
Date of disclosure of the study information 2016/04/12
Last modified on 2016/04/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.