UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029388 |
|---|---|
| Receipt number | R000033583 |
| Scientific Title | The exploratory research on improvements in the immune system of the algae food intake A randomized, placebo-controlled, double-blind cross-over trial |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2025/03/05 11:21:27 |
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Basic information
Public title
The exploratory research on improvements in the immune system of the algae food intake
A randomized, placebo-controlled, double-blind cross-over trial
Acronym
The research on improvements in the immune system of the algae food intake
Scientific Title
The exploratory research on improvements in the immune system of the algae food intake
A randomized, placebo-controlled, double-blind cross-over trial
Scientific Title:Acronym
The research on improvements in the immune system of the algae food intake
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
improvements in the immune system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immune function
Key secondary outcomes
Efficacy
Objective evaluation
feeling questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
algal food
Interventions/Control_2
placebo control 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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
(1)Healty people who are 30 or more to less than 70 years old with experiencing fatigue and stress.
(2)male.
(3)Those who tend to be in poor health condition.
(4)Individuals who are healthy and are not suffered from a chronic malady.
(5)Those who are not currently smoking cigarettes.
(6)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)Individuals who intake laxatives, antiflatulent etc. aiming to improve bowel movements.
(4)Individuals who have a serious disease history or current medical history
(5)Individuals with serious anemia.
(6)Individuals who changed health food within the past 4 weeks or who started using it newly.
(7)Individuals who have been exposed to ultraviolet rays beyond their daily life within the past 4 weeks.
(8)Individuals who have irregular or disturbed life style such as night shifts.
(9)Individuals who are receiving treatment at a medical institution or those who judged to be in the relevant condition requires treatment.
(10)Individuals who have the following medical history : severe diseases (such as sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory organs, respiratory organs, endocrine system, the nervous system), or psychiatric diseases.
(11)Individuals who have history of alcohol and drug dependence.
(12)Individuals who have participated in other clinical studies within the past 1 year.
(13)Individuals judged inappropriate for the study by the principal.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ohno Naohito |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Laboratory for Immunopharmacology of Microbial Products
Zip code
Address
1432-1 Horinouchi, Hachioji, Tokyo 192-0392 Japan
TEL
042-676-5561
ohnonao@toyaku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ootani Kazuyoshi |
Organization
KOBELCO ECO-SOULUTIONS CO.,LTD
Division name
Algae Business Promotion Dept.
Zip code
Address
4-78, 1-chome, Wakinohama-cho, Chuo-ku, Kobe 651-0072, Japan
TEL
078-232-8223
Homepage URL
k.otani@kobelco-eco.co.jp
Sponsor or person
Institute
UNITIKA GARMENTS TECNOLOGY & RESEARCH LABORATORIES. 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
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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/11/5/1144
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/11/5/1144
Number of participants that the trial has enrolled
7
Results
The test food group showed a significant increase in salivary secretory immunoglobulin A (sIgA) concentration and secretion rate after consumption compared to the placebo group. The Mental Component Summary of SF-12 was also significantly increased in the test food group compared to the placebo food group.
The original paper reporting the results is as follows:
Effects of Euglena gracilis EOD-1 Ingestion on Salivary IgA Reactivity and Health-Related Quality of Life in Humans, Nutrients, 11(5), 1144 (2019)
Results date posted
| 2025 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 22 | Day |
Baseline Characteristics
Healthy males whose age of 30 years or more and less than 70 years
Participant flow
Completed(n=13)
Analyzed(n=7)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Immune function
Efficacy
Objective evaluation
feeling questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 03 | 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
| 2017 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033583
