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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043804
Receipt No. R000050001
Scientific Title The effect of ingestion of fucoidan derived from Cladosiphon okamuranus Tokida on human NK cells: A randomized, double-blind, placebo-controlled trial.
Date of disclosure of the study information 2021/04/03
Last modified on 2021/04/01

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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


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