UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002821 |
|---|---|
| Receipt number | 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 14:58:51 |
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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
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
Sponsor or person
Institute
Kobe University. School of Medicine Dept. General Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003439
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