UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043804
Receipt number 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 14:33:06

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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 or person

Institute

KSO Corporation

Institute

Department

Personal name



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

Value
https://center6.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