UMIN-CTR Clinical Trial

Basic information
Public title	Effects of high beta-glucan barley rice on visceral fat obesity in Japanese subjects. A randomized double blind placebo-controlled study
Acronym	Effects of high beta-glucan barley rice on visceral fat obesity
Scientific Title	Effects of high beta-glucan barley rice on visceral fat obesity in Japanese subjects. A randomized double blind placebo-controlled study
Scientific Title:Acronym	Effects of high beta-glucan barley rice on visceral fat obesity
Region	Japan

Condition
Condition	visceral fat obesity
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of high beta-glucan barley rice intake for 12 weeks on visceral fat accumulation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	change in visceral fat area
Key secondary outcomes	1) body weight, waist circumference, subcutaneous fat area, total fat area 2) total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol 3) HbA1c, insulin, free fatty acid, fasting blood sugar 4) leptin, adiponectin 5) blood pressure 6) questionnaire survey about eating behavior and psychosomatic state

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	intake of 200 grams of high beta-glucan barley rice twice daily for 12 weeks
Interventions/Control_2	intake of 200 grams of barley rice without beta-glucan twice daily for 12 weeks
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	30 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) age between 30 and 70 years old at consent 2) waist circumference >=85 cm (man), >=90 cm (woman) 3) subjects understand the study procedures and agree to participate in the study by giving informed consent prior to the study.
Key exclusion criteria	1) experienced body weight changes >= 10% within a year before the start date of this study 2) attended another clinical study within a month before the start date of this study 3) Fasting blood sugar >=126 mg/dl or HbA1c (NGSP) >=6.5% or diabetic patient 4) has history of serious cardiovascular diseases 5) has history of surgery in gastrointestinal tract 6) takes drugs to treat dyslipidemia 7) has continuous intake of dietary fiber supplement or beta glucan (barley, mushroom, black yeast, etc) 8) has continuous intake of Divaricate Saposhnikovia Miraculous Powder 9) has serious liver or kidney disease 10) has history of malignant diseases 11) has serious infectious diseases 12) pregnant or lactating woman 13) allergic to raw materials 14) is not appropriate in the investigator's opinion
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsuyuki Miura
Organization	Osaka City University Medical School
Division name	Applied Pharmacology and Therapeutics
Zip code
Address	1-4-3 Asahimachi, Abeno, Osaka
TEL	06-6645-3787
Email	miura-pha@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hisako Fujii
Organization	Osaka city University Hospital
Division name	Center for Drug & Food Clinical Evaluation
Zip code
Address	1-2-7 Asahimachi, Abeno, Osaka
TEL	06-6645-3443
Homepage URL
Email	hfujii@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka city University Hospital
Institute
Department

Funding Source
Organization	Faculty of Home Economics, Otsuma Women's University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	大阪市立大学医学部附属病院　Osaka City University Hospital

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 08 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	Completed
Date of protocol fixation	2014 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date	2014 Year 08 Month 23 Day
Last follow-up date	2014 Year 11 Month 30 Day
Date of closure to data entry	2014 Year 12 Month 26 Day
Date trial data considered complete	2014 Year 12 Month 26 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 08 Day
Last modified on	2014 Year 12 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017163

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.