UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024995 |
|---|---|
| Receipt number | 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 19:34:03 |
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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
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
k.wasaki@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028758
