UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050710