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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002821
Receipt No. R000003439
Scientific Title The effect of KOMBU (seaweed) on the visceral fat in men
Date of disclosure of the study information 2009/12/04
Last modified on 2010/03/10

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Basic information
Public title The effect of KOMBU (seaweed) on the visceral fat in men
Acronym The effect of KOMBU on visceral fat
Scientific Title The effect of KOMBU (seaweed) on the visceral fat in men
Scientific Title:Acronym The effect of KOMBU on visceral fat
Region
Japan

Condition
Condition Obesity
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Fucoxanthin, which KOMBU contains, is thought to have preventive effect on visceral fat. However, there have been no reports on its safety in men. In this study, we try to confirm its clinical safety after oral administration.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Physical findings including vital signs, blood serum chemicals including liver enzymes, creatinine, etc., and urine analysis.
Key secondary outcomes Evaluate visceral fat area by computed tomography

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Fucoxanthin capsule which contains 4mg, 1po bid for 28 days.
Pre-and post intake, we evaluate physical findings, abdominal CT for visceral fat area, blood chemicals and urine analysis.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Healthy male adult volunteers
Key exclusion criteria Patients who need medical treatment.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hozuka Akita
Organization Kobe University. School of Medicine.
Division name Dept. General Internal Medicine
Zip code
Address 7-5-2 Kusunoki-cho,Chuo-ku,Kobe
TEL 078-382-6596
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masayoshi Hashimoto
Organization Kobe University. School of Medicine.
Division name Dept. Family & Community Medicine
Zip code
Address 7-5-2 Kusunoki-cho,Chuo-ku,Kobe
TEL 078-382-6596
Homepage URL
Email

Sponsor
Institute Kobe University. School of Medicine Dept. General Internal Medicine
Institute
Department

Funding Source
Organization Japan Food Research & Development Institute Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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 神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 04 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
2009 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 01 Day
Last modified on
2010 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003439

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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