UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024390 |
|---|---|
| Receipt number | 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 11:34:11 |
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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
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
nosehir@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028060
