![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | life style related diseases and heat illness | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |