UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the immune response by ingestion of a fucoidan-containing food in adult males and females : a randomized, double blind, placebo-controlled, parallel-group trial
Title of the study (Brief title)	A study for evaluating the immune response by ingestion of a fucoidan-containing food in adult males and females
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the the immune response by ingestion of a fucoidan-containing food for 12 weeks in subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	salivary s-IgA secretion rate
Key secondary outcomes	salivary sIgA concentration, POMS2, Fatigue VAS, PSQI-j, Intraoral questionnaire

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 a fucoidan-containing food for 12 weeks.
Interventions/Control_2	Ingestion of placebo without a fucoidan 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) Males and females from 20 years of age or older to under 65 years of age 2) A lower salivary secretory immunoglobulin A secretion rate 3) POMS2-AS FI T score is more than 50 and VA T score is less than 50
Key exclusion criteria	1) Subjects who use fucoidan-containing food or fucoidan fortified food 2) Subjects taking medicine and quasi drug (e.g., immunosuppressant, steroid) which may influence immune function 3) Subjects routinely taking health supplements which may influence immune function 4) Subjects who are under medication (e.g., hyposensitization) which may influence the outcome of the study 5) Subjects who have a history of the allergic disease 6) Subjects who have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care 7) Subjects who have oral or dental problems with bleeding 8) Night and day shift worker or manual laborer 9) Subjects who have carried out an intense activity (e.g., marathon race) 10) Subjects who cannot carry out a procedure of various inspection by the rule during the study period 11) Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor 12) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion 13) Subjects having possibilities for emerging allergy related to the study 14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 15) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 16) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 17) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 18) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	60

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-shi,Okinawa
TEL	098-994-1048
Email	k-ina.hk@kanehide.co.jp

Public contact
Name of contact person	Kunihiko Wasaki
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.wasaki@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	2016 Year 11 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 10 Day
Anticipated trial start date	2016 Year 11 Month 28 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	2016 Year 11 Month 25 Day
Last modified on	2018 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028758