UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021879 |
|---|---|
| Receipt number | 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 11:01:43 |
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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
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
nosehir@shinshu-u.ac.jp
Public contact
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
nosehir@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025227
