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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044697
Receipt No. 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

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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
Email 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
Email abe@mozuku-1ban.jp

Sponsor
Institute Department of Biotechnology, Maebashi Institute of Technology
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050710

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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