UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014957 |
|---|---|
| Receipt number | R000017404 |
| Scientific Title | The combined effects of interval walking training and dried soy bean curd on health promotion. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2014/08/26 15:36:03 |
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Basic information
Public title
The combined effects of interval walking training and dried soy bean curd on health promotion.
Acronym
Health promotion effects of dried soy bean curd
Scientific Title
The combined effects of interval walking training and dried soy bean curd on health promotion.
Scientific Title:Acronym
Health promotion effects of dried soy bean curd
Region
| Japan |
Condition
Condition
life style related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine whether dried soy bean curd intake accelerate the increase in physical fitness and improvement of life style related diseases caused by exercise training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical fitness & symptoms of life-style related diseases
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) 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
Dried soy bean curd intake
Interventions/Control_2
Placebo intake
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
| 55 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Those who have performed interval walking training for more tha 6 months in the Health Promotion Program for over 40s in Matsumoto.
Key exclusion criteria
1) Systolic blood pressure is more than 151 mmHg and diastolic pressure is more than 91mmHg.
2) Those who have allergic reaction to dried soy bean curd.
3)Those who cannot continue to perform interval walking training.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nose |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Sports Medical Sciences
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 | Naomi Ishikura |
Organization
Shinshu University
Division name
School of Medicine
Zip code
Address
3-1-1 Asahi, Matsumoto
TEL
0263-37-2572
Homepage URL
ishikura_naomi@gm.shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagano dried soy bean industrial association
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 05 | 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
| 2014 | Year | 08 | Month | 26 | Day |
Last modified on
| 2014 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017404
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
