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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024995
Receipt No. R000028758
Scientific Title 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
Date of disclosure of the study information 2016/11/27
Last modified on 2018/02/28

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Basic information
Public title 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
Acronym A study for evaluating the immune response by ingestion of a fucoidan-containing food in adult males and females
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Keiichiro Inafuku
Organization KANEHIDE BIO Co., Ltd.
Division name Research and Development Department
Zip code
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
1st name
Middle name
Last name Kunihiko Wasaki
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
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)

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
2016 Year 11 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 11 Month 10 Day
Date of IRB
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

Other
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

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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