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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014957
Receipt No. 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

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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
Email 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
Email ishikura_naomi@gm.shinshu-u.ac.jp

Sponsor
Institute Shinshu University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017404

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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