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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014793
Receipt No. R000017163
Scientific Title Effects of high beta-glucan barley rice on visceral fat obesity in Japanese subjects. A randomized double blind placebo-controlled study
Date of disclosure of the study information 2014/08/08
Last modified on 2014/12/26

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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://upload.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


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