UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043804 |
|---|---|
| Receipt number | R000050001 |
| Scientific Title | The effect of ingestion of fucoidan derived from Cladosiphon okamuranus Tokida on human NK cells: A randomized, double-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2021/04/03 |
| Last modified on | 2021/04/01 14:33:06 |
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Basic information
Public title
The effect of ingestion of fucoidan derived from Cladosiphon okamuranus on human NK cells.
Acronym
The effect of ingestion of fucoidan derived from Cladosiphon okamuranus on human NK cells.
Scientific Title
The effect of ingestion of fucoidan derived from Cladosiphon okamuranus Tokida on human NK cells: A randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym
The effect of ingestion of fucoidan derived from Cladosiphon okamuranus Tokida on human NK cells: A randomized, double-blind, placebo-controlled trial.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of fucoidan ingestion of NK cells in healthy adult
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of NK cell activity (from the start of ingestion to 12 weeks later)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
To ingest 3g / day of fucoidan food for 12 weeks
Interventions/Control_2
To ingest Placebo food 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) Healthy adult man and woman over 20 years old and under 65 years old
2) Persons who voluntarily agreed to participate in writing after understanding the purpose of the study
Key exclusion criteria
1)Persons who have a serious disease, are undergoing treatment, have a medical history
2)Persons who have a chronic disease and regularly use drugs
3)Persons who regularly use supplements/health foods (including foods for specified health use and foods with functional claims) that may affect immunity
4)Persons who constantly drink more than proper drinking (500 mL per bottle of beer on average per day)
5)Persons who cannot stop drinking from 2 days before each test
6)Persons who have been declared to have allergies
7)Persons with a history of gastrointestinal diseases and gastrointestinal surgery
8)Persons who participants in trials using other foods, medicines and cosmetics
9)Persons who are pregnant, willing to become pregnant during the test period, or breastfeeding
10)Person who the doctor responsible for the study deems inappropriate as a subject
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Tomori |
Organization
South Product Co., Ltd
Division name
Research and development
Zip code
904-2311
Address
5194-71 Katsuren Haebaru, Uruma city, Okinawa, Japan
TEL
098-982-1272
m-tomori@south-p.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Tomori |
Organization
South Product Co., Ltd
Division name
Research and development
Zip code
904-2311
Address
5194-71 Katsuren Haebaru, Uruma city, Okinawa, Japan
TEL
098-982-1272
Homepage URL
m-tomori@south-p.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
South Product 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
Nihonbashi cardiology clinic
Address
13-4 Kodenmacho Nihonbashi, Chuo-ku, Tokyo, Japan
Tel
03-5641-4133
shiken@kso.co.jp
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
| 2021 | Year | 04 | Month | 03 | 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
40
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
for reanalysis of study data.
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 | 03 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050001
