UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety Evaluation of Long-Term Ingestion of Cladosiphon okamuranus Fucoidan in Healthy Subjects. A Randomized, Double-blind, Placebo-controlled, Parallel Study.
Title of the study (Brief title)	Safety Evaluation of Long-Term Ingestion of Cladosiphon okamuranus Fucoidan in Healthy Subjects.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety of Long-term ingestion of recommended daily intake in Cladosiphon okamuranus Fucoidan containing drink for 12 weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
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 4 weeks, 8 weeks and 12 weeks ingestion.
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	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion Cladosiphon okamuranus Fucoidan of recommended daily intake in test drink for 12 weeks.
Interventions/Control_2	A placebo drink(not containing Cladosiphon okamuranus Fucoidan) intake 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. 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

Research contact person
Name of lead principal investigator	Haruhi Sugimura
Organization	C'est la vie Shinbashi Clinic
Division name	Medical Office
Address	2-39-3 Nishishinbashi, Minato-ku, Tokyo
TEL	03-5408-8181
Email	h-sugimura@shinkokai.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales Department
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	SOUTH PRODUCT Co., Ltd
Institute
Department

Funding Source
Organization	Fisheries Division, Department of Agriculture, Forestry and Fisheries, Okinawa Prefectural Government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

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	2017 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 12 Day
Anticipated trial start date	2016 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 25 Day
Last modified on	2017 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032471