UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056792 |
|---|---|
| Receipt number | R000064911 |
| Scientific Title | Effect of Hot Water Extract of Edible Blue-Green Algae, Nostoc flagelliforme (Hair Vegetables), on Salivary Secretory IgA. |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/23 11:43:17 |
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Basic information
Public title
Effect of Hot Water Extract of Edible Blue-Green Algae, Nostoc flagelliforme (Hair Vegetables), on Salivary Secretory IgA.
Acronym
Effects of Edible Blue-Green Algae Extracts on Salivary IgA.
Scientific Title
Effect of Hot Water Extract of Edible Blue-Green Algae, Nostoc flagelliforme (Hair Vegetables), on Salivary Secretory IgA.
Scientific Title:Acronym
Effects of Edible Extracts on Salivary IgA.
Region
| Japan |
Condition
Condition
Healthy Adult Men and Women Aged 20 and Over
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of ingesting hot water extracts of edible blue-green algae, Nostoc flagelliforme (Hair Vegetables), on the concentration of immunoglobulin A (IgA) in saliva. IgA is an essential component of mucosal immunity, particularly involved in respiratory infection prevention and oral health maintenance. This extract is highly nutritious and is expected to have immunomodulatory effects, which will be scientifically evaluated in this study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
In the intervention group, salivary IgA concentration increases.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will consume 100 mL of the food extract within one minute.
Interventions/Control_2
Subjects will consume 100 mL of water within one minute.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy Adult Men and Women.
Key exclusion criteria
Individuals who are pregnant or breastfeeding, those with chronic diseases, and those taking immunosuppressive drugs.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | RYOJI |
| Middle name | |
| Last name | HIROTA |
Organization
Matsumoto University
Division name
Graduate School of Health Sciences
Zip code
390-1241
Address
2095-1, NIIMURA,MATSUMOTO,NAGANO,JAPAN
TEL
0263487381
ryoryo2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | RYOJI |
| Middle name | |
| Last name | HIROTA |
Organization
Matsumoto University
Division name
2095-1, NIIMURA,MATSUMOTO,NAGANO,JAPAN
Zip code
390-1241
Address
2095-1, NIIMURA,MATSUMOTO,NAGANO,JAPAN
TEL
0263487381
Homepage URL
ryoryo2003@yahoo.co.jp
Sponsor or person
Institute
Matsumoto University
Institute
Department
Personal name
Funding Source
Organization
Microalgae Corporation 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
MATSUMOTO UNIVERSITY
Address
2095-1, NIIMURA,MATSUMOTO,NAGANO,JAPAN
Tel
0263487381
ryoryo2003@yahoo.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
松本大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064911
