UMIN-CTR Clinical Trial

Basic information
Public title	The effect of ingestion of fucoidan derived from Cladosiphon okamuranus on human NK cells.
Acronym	The effect of ingestion of fucoidan derived from Cladosiphon okamuranus on human NK cells.
Scientific Title	The effect of ingestion of fucoidan derived from Cladosiphon okamuranus Tokida on human NK cells: A randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym	The effect of ingestion of fucoidan derived from Cladosiphon okamuranus Tokida on human NK cells: A randomized, double-blind, placebo-controlled trial.
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 ingestion of NK cells in healthy adult
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of NK cell activity (from the start of ingestion to 12 weeks later)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	To ingest 3g / day of fucoidan food for 12 weeks
Interventions/Control_2	To ingest Placebo food for 12 weeks
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy adult man and woman over 20 years old and under 65 years old 2) Persons who voluntarily agreed to participate in writing after understanding the purpose of the study
Key exclusion criteria	1)Persons who have a serious disease, are undergoing treatment, have a medical history 2)Persons who have a chronic disease and regularly use drugs 3)Persons who regularly use supplements/health foods (including foods for specified health use and foods with functional claims) that may affect immunity 4)Persons who constantly drink more than proper drinking (500 mL per bottle of beer on average per day) 5)Persons who cannot stop drinking from 2 days before each test 6)Persons who have been declared to have allergies 7)Persons with a history of gastrointestinal diseases and gastrointestinal surgery 8)Persons who participants in trials using other foods, medicines and cosmetics 9)Persons who are pregnant, willing to become pregnant during the test period, or breastfeeding 10)Person who the doctor responsible for the study deems inappropriate as a subject
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Tomori
Organization	South Product Co., Ltd
Division name	Research and development
Zip code	904-2311
Address	5194-71 Katsuren Haebaru, Uruma city, Okinawa, Japan
TEL	098-982-1272
Email	m-tomori@south-p.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Tomori
Organization	South Product Co., Ltd
Division name	Research and development
Zip code	904-2311
Address	5194-71 Katsuren Haebaru, Uruma city, Okinawa, Japan
TEL	098-982-1272
Homepage URL
Email	m-tomori@south-p.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	South Product Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihonbashi cardiology clinic
Address	13-4 Kodenmacho Nihonbashi, Chuo-ku, Tokyo, Japan
Tel	03-5641-4133
Email	shiken@kso.co.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 04 Month 03 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	40
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	for reanalysis of study data.
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	2016 Year 03 Month 10 Day
Date of IRB	2016 Year 07 Month 04 Day
Anticipated trial start date	2016 Year 06 Month 17 Day
Last follow-up date	2016 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 01 Day
Last modified on	2021 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050001

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.