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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024390
Receipt No. R000028060
Scientific Title The preventive effects of rice intake on lifestyle-related diseases which is treated with hyperbaria before polished.
Date of disclosure of the study information 2016/10/13
Last modified on 2016/10/13

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Basic information
Public title The preventive effects of rice intake on lifestyle-related diseases which is treated with hyperbaria before polished.
Acronym The effects of hyperbaria-treated rice intake
Scientific Title The preventive effects of rice intake on lifestyle-related diseases which is treated with hyperbaria before polished.
Scientific Title:Acronym The effects of hyperbaria-treated rice intake
Region
Japan

Condition
Condition Lifetyple-related diseases
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To examine whether interval walking training + hyperbaria-treated rice intake improves the symmtoms of lifestyle-related diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The indices of lifestyle-related diseases (hypertension, hyperglycemia, obesity, dyslipidemia)
Key secondary outcomes Methylation of inflammatory genes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 Interval walking training + hyperbaria-treated rice
Intervention period: 4 months
Frequency of intake: breakfast and dinner (2 times/day)
Amount of intake: 150g/meal
Interventions/Control_2 Interval walking training + usual rice.
Intervention period: 4 months
Frequency of intake: breakfast and dinner (2 times/day)
Amount of intake: 150g/meal
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Those who had performed interval walking training more than 6 months.
2) Systolic blood pressure = not less than 130mmHG or Diastolic blood pressure = not less than 85mmHg
3) Fasting blood pressure = not less than 110mg/dl or HbA1c= not less than 6.2%
Key exclusion criteria 1) Those who have difficaluty in walking
2) Those who have allergc response to rice
3) Those who the chief investigator judge as unappropriate subjects
Target sample size 60

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, 390-8621
TEL 0263-37-2681
Email nosehir@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Nose
Organization Shinshu University Graduate School of Medicine
Division name Department od Sports Medical Sciences
Zip code
Address 3-1-1 Asahi Matsumoto, 390-8621
TEL 0263-37-2681
Homepage URL
Email nosehir@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization the Ministry of Agriculture, Forestry and Fisheries
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 10 Month 13 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
2016 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 04 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 10 Month 13 Day
Last modified on
2016 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028060

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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