UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009799 |
|---|---|
| Receipt number | R000011477 |
| Scientific Title | Study on lifestyle-related disease improvement effect by the kombu intake |
| Date of disclosure of the study information | 2013/01/17 |
| Last modified on | 2016/01/18 08:50:16 |
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Basic information
Public title
Study on lifestyle-related disease improvement effect by the kombu intake
Acronym
Study on lifestyle-related disease improvement effect by the kombu
Scientific Title
Study on lifestyle-related disease improvement effect by the kombu intake
Scientific Title:Acronym
Study on lifestyle-related disease improvement effect by the kombu
Region
| Japan |
Condition
Condition
Hypertension, hyperlipemia, gout, glycohemia, diabetes, abnormal glucose tolerance, a fatty liver, obstipation, healthy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Cardiology |
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this research, a healthy volunteer, hypertension patient, a hyperlipemic subject, a gout patient, a glycohemia patient, a diabetic, an abnormal-glucose-tolerance patient, a fatty liver patient, or an obstipation patient take in the kombu, and ingestion of the kombu verifies how it has contributed to our health by considering the influence on measurement of blood sugar, blood lipid, etc., the stomach and intestines, and bowels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity of the kombu intake to hypertension, hyperlipemia, gout, glycohemia, diabetes, abnormal glucose tolerance, a fatty liver, and obstipation-Evaluation of blood components, urine components and various pathological condition
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
kombu intake for 4 weeks (6 g/1 day)>> Non intake for 4 weeks
or
Non intake for 4 weeks >> kombu intake for 4 weeks (6 g/1 day)
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) Person who does not present allergy to the kombu
2) Person aged 20 and over
3) Person by whom written consent was got from the person himself/herself
4) Person who does not have thyroid disease
Key exclusion criteria
The case that is judged that doctors are unsuitable
Target sample size
540
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
Division of Gastroenterology
Zip code
Address
7-5-1 Kusunoki-cho, Chu-o-ku, Kobe, Hyogo 650-0017, Japan.
TEL
078-382-6305
myoshida@med.kobe-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
Division of Gastroenterology
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
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
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
| 2013 | Year | 01 | Month | 17 | 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 | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 17 | Day |
Last modified on
| 2016 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011477
