UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014793 |
|---|---|
| Receipt number | 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 17:33:25 |
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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
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
hfujii@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka city University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017163
