UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008240 |
|---|---|
| Receipt number | R000009719 |
| Scientific Title | Study on the lifestyle-related disease protective efficacy by an intake of Kombu |
| Date of disclosure of the study information | 2012/06/24 |
| Last modified on | 2016/01/25 08:34:55 |
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Basic information
Public title
Study on the lifestyle-related disease protective efficacy by an intake of Kombu
Acronym
Study on the lifestyle-related disease protective efficacy by an intake of Kombu
Scientific Title
Study on the lifestyle-related disease protective efficacy by an intake of Kombu
Scientific Title:Acronym
Study on the lifestyle-related disease protective efficacy by an intake of Kombu
Region
| Japan |
Condition
Condition
not applicable_Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, healthy volunteers take in Kombu, and it is scientifically investigated how an intake of Kombu, which rooted in our eating habits for a long time, contributes to our health by examining the blood glucose and lipid levels and its influence on stomach, intestine and bowel movement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood: perform the general blood test,
biochemical examination, and analysis of metabolites such as organic acids and fatty acids.
Urine: perform the analysis of glucose, proteins, organic acids and fatty acids.
Feces: perform the analysis of intestinal flora using the genome DNA (do not analyze human genome DNA) and the analysis of metabolites such as organic acids and fatty acids.
Questionnaire: questionary survey until the intake of Kombu end before the intake start.
Intake period: A Kombu intake period is four weeks, and the evaluations mentioned above are carried out after the intake, during the intake and before the intake.
Key secondary outcomes
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
In this study, dry Kombu is used, and
1.5 g or 3.0 g of dry Kombu per day is taken by healthy volunteers for four weeks. When healthy volunteers take in Kombu, dry Kombu is soften with water, and then it is eaten.
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 and Female
Key inclusion criteria
1) The person who is not allergic to Kombu.
2) The persons 20 years or older.
3) The person that the written agreement was provided from the person himself.
4) The persons who does not have a thyreoid diseases.
Key exclusion criteria
1) An agreement is not provided for this study.
2) The doctors judge that the participation is inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Yoshida |
Organization
Kobe University Graduate School of Medicine
Division name
Metabolomics research
Zip code
Address
7-5-1 Kusunoki-cho, Chu-o-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6305
myoshida@med.kbe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Yoshida |
Organization
Kobe University Graduate School of Medicine
Division name
Metabolomics research
Zip code
Address
7-5-1 Kusunoki-cho, Chu-o-ku, Kobe, Hyogo 650-0017, Japan
TEL
078-382-6305
Homepage URL
myoshida@med.kobe-u.ac.jp
Sponsor or person
Institute
Metabolomics research, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding 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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 24 | 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
| 2012 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | 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
| 2012 | Year | 06 | Month | 24 | Day |
Last modified on
| 2016 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009719
