UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037042 |
|---|---|
| Receipt number | R000042187 |
| Scientific Title | The effect of the algae food intake on athletes immunity Open study |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2020/06/12 11:10:59 |
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Basic information
Public title
The effect of the algae food intake on athletes immunity
Open study
Acronym
The effect of the algae food intake on athletes immunity
Scientific Title
The effect of the algae food intake on athletes immunity
Open study
Scientific Title:Acronym
The effect of the algae food intake on athletes immunity
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the algal food intake to athlete immunity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
secretory immunoglobulin A
Key secondary outcomes
Body composition, Subjective evaluation (Feeling of Fatigue, Feeling)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
To intake algal food
Interventions/Control_2
Not to intake algal food
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
(1)Healthy man who are 20 or more to less than 40 years old
(2)Healthy people who are not currently treating any visceral disease
(3)Those from whom a written consent can be obtained on a voluntary basis
Key exclusion criteria
(1)Individuals using medical products
(2)Individuals who are prone to allergies for foods
(3)Individiuals who has a history of serious disease / current illness
(4)Individiuals who has a history of alcohol and drug addiction
(5)Individiuals who is unsuitable for the entry judged by a officer
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Takahashi |
Organization
KOBELCO ECO-SOULUTIONS CO.,LTD
Division name
Technical Develop Center
Zip code
651-2241
Address
1-1-4, Murotani, Nishi-ku, Kobe 651-2241
TEL
078-992-6957
md.takahashi@kobelco-eco.co.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Takahashi |
Organization
KOBELCO ECO-SOULUTIONS CO.,LTD
Division name
Technical Develop Center
Zip code
651-2241
Address
1-1-4, Murotani, Nishi-ku, Kobe 651-2241
TEL
078-992-6957
Homepage URL
md.takahashi@kobelco-eco.co.jp
Sponsor or person
Institute
KOBELCO ECO-SOULUTIONS CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
KOBELCO ECO-SOULUTIONS 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
The ethical committee of the Hokubukai Group Utukushigaoko Hospital
Address
61-1, Shinei, Kiyota-ku, Sapporo, 004-0839, Japan
Tel
011-882-0111
wakimoto@ughp-cpc.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
| 2020 | Year | 06 | Month | 12 | 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
24
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
| 2019 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042187
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
