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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027560
Receipt No. R000031594
Official scientific title of the study A study to evaluate the safety of excessive ingestion of seaweed extract containing foods for healthy adults.
Date of disclosure of the study information 2018/08/06
Last modified on 2017/11/30

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Basic information
Official scientific title of the study A study to evaluate the safety of excessive ingestion of seaweed extract containing foods for healthy adults.
Title of the study (Brief title) A study to evaluate the safety of excessive ingestion of seaweed extract containing foods.
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive ingestion of seaweed extract containing foods for 4 weeks.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight
Doctor's questions
Adverse event
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of seaweed extract containing foods (30 tablets per day, 4 weeks)
Interventions/Control_2
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
64 years-old >=
Gender Male and Female
Key inclusion criteria Healthy males and females aged 20-64 years.
Key exclusion criteria (1) Subjects who use health food containing large amount of seaweed extract.
(2) Subjects who has a disease under treatment.
(3) Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, heart disease or cancer).
(4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination.
(5) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work and overseas.
(6) Subjects who have participated in other clinical study within the last one month prior to the current study.
(7) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(9) Subjects who are judged as unsuitable by doctor for other reasons.
Target sample size 11

Research contact person
Name of lead principal investigator Keiichiro Inafuku
Organization KANEHIDE BIO Co., Ltd.
Division name Research and development department
Address 5-2-2, Nishizakicho, Itoman, Okinawa
TEL 098-994-1048
Email k-ina.hk@kanehide.co.jp

Public contact
Name of contact person Saki Fukuchi
Organization TTC Co.,Ltd
Division name Clinical Research Planning Department
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email s.fukuchi@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd
Institute
Department

Funding Source
Organization KANEHIDE BIO Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 08 Month 06 Day

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 05 Month 25 Day
Anticipated trial start date
2017 Year 06 Month 05 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 Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031594

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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