UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044697 |
|---|---|
| Receipt number | R000050710 |
| Scientific Title | Evaluation of the intestinal environment improving effect of fucoidan |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2021/06/26 08:38:19 |
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Basic information
Public title
Evaluation of the intestinal environment improving effect of fucoidan
Acronym
Evaluation of the intestinal environment improving effect of fucoidan
Scientific Title
Evaluation of the intestinal environment improving effect of fucoidan
Scientific Title:Acronym
Evaluation of the intestinal environment improving effect of fucoidan
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of fucoidan intake on the intestinal flora
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intestinal flora
Key secondary outcomes
Organic acids (short chain fatty acids), low molecular weight metabolites
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1) Ingestion period
Initially, subjects do not ingest fucoidan food for 14 days. The subject then continues to intake fucoidan food for 14 days.
2) Intake
To ingest 30 mL / day of fucoidan food for 14 days
A fucoidan food with a daily intake of 30 mL contains a dry weight of 810 mg of fucoidan.
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) Healthy adult man and woman
2) Persons who voluntarily agreed to participate in writing after understanding the purpose of the study through informed consent
Key exclusion criteria
none
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Hoshi |
Organization
Maebashi Institute of Technology
Division name
Department of Biotechnology
Zip code
371-0816
Address
460-1 kamisadori-machi, maebashi, Gunma 371-0816, Japan
TEL
027-265-7373
hihoshi@maebashi-it.ac.jp
Public contact
Name of contact person
| 1st name | Sunao |
| Middle name | |
| Last name | Abe |
Organization
Marine Products Kimuraya Co., Ltd.,
Division name
R and D division
Zip code
684-0072
Address
3307 Watari-cho, Sakaiminato, Tottori 684-8790, Japan
TEL
0859-45-6555
Homepage URL
abe@mozuku-1ban.jp
Sponsor or person
Institute
Department of Biotechnology, Maebashi Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
R and D division, Marine Products Kimuraya 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
Human Function Experiment Ethics Review Committee of the Maebashi Institute of Technology
Address
460-1 kamisadori-machi, maebashi, Gunma 371-0816, Japan
Tel
027-265-0111
ynomura@maebashi-it.ac.jp
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
| 2021 | Year | 12 | Month | 01 | 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
6
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
| 2020 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 29 | Day |
Last modified on
| 2021 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050710
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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