UMIN-CTR Clinical Trial

Public title

Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects. A Randomized, Double-blind, Placebo-controlled, Parallel Study.

Acronym

Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects.

Scientific Title

Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects. A Randomized, Double-blind, Placebo-controlled, Parallel Study.

Scientific Title:Acronym

Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects.

Region

Japan

Condition

No applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety of excessive ingestion of Cladosiphon okamuranus Fucoidan drink containing 4-fold of recommended daily intake.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety evaluation items:
Examination by a physician in charge, physical examination findings, clinical laboratory findings(Hematological test, Biochemical test, Urine test), subject symptoms at 2 weeks and 4 weeks ingestion.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of 4-fold Cladosiphon okamuranus Fucoidan of recommended daily intake in test drink for 4 weeks.

Interventions/Control_2

A placebo drink(not containing Cladosiphon okamuranus Fucoidan) intake for 4 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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. People whose defecation frequency is no fewer than 3 nor more than 5.
2. Who usually have three meals a day.
3. Who gave the informed consents in writing after receiving enough explanation of purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.

Key exclusion criteria

People who meet any of the following conditions will be excluded.
1. Who regularly use intestinal drugs and laxative (including strong laxatives and enema)
2. Who can not stop intake the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) during the screening period.
3. Who use medicine such as antibiotics that affect digestion and absorption.
4. Who can not stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relive constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during the screening period.
5. Who have allergic to food.
6. Who have serious diseases requiring an urgent treatment, or who accept severe complication.
7. Who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendicectomy).
8. Who are judged unsuitable for this study based on subject questionnaire.
9. Who is pregnant or willing to be pregnant or brest-feeding during this study.
10. Who has a current or history of drug dependence and/or alcoholism.
11. Who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that.
12. Who are judged unsuitable for this study by test responsibility doctor.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuya Kozuma

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Director

Zip code

Address

1-2-70 Konan, Minato-Ku, Tokyo

TEL

03-3452-3381

Email

shibaurakenkan@sempos.or.jp

Name of contact person

1st name
Middle name
Last name	Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales Department

Zip code

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL

Email

yoshikawa@kso.co.jp

Institute

SOUTH PRODUCT Co., Ltd

Institute

Department

Personal name

Organization

Fisheries Division, Department of Agriculture, Forestry and Fisheries, Okinawa Prefectural Government

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

05

Month

27

Day

Date of IRB

Anticipated trial start date

2016

Year

06

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

25

Day

Last modified on

2017

Year

07

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032474