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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028368
Receipt No. R000032474
Scientific Title Safety evaluation of excessive ingestion of Cladosiphon okamuranus Fucoidan in healthy subjects. A Randomized, Double-blind, Placebo-controlled, Parallel Study.
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/25

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

Objectives
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

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 2 weeks and 4 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 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

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
Last 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

Public contact
1st 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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
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=R000032474

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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