UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The preventive effects of rice intake on lifestyle-related diseases which is treated with hyperbaria before polished.
Title of the study (Brief title)	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	Hiroshi Nose
Organization	Shinshu University Graduate School of Medicine
Division name	Department of Sports Medical Sciences
Address	3-1-1 Asahi Matsumoto, 390-8621
TEL	0263-37-2681
Email	nosehir@shinshu-u.ac.jp

Public contact
Name of contact person	Hiroshi Nose
Organization	Shinshu University Graduate School of Medicine
Division name	Department od Sports Medical Sciences
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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