UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060752 |
|---|---|
| Receipt number | R000069476 |
| Scientific Title | Effects of hot-water extract of edible cyanobacteria Nostoc commune on salivary secretory IgA: a randomized crossover trial |
| Date of disclosure of the study information | 2026/02/28 |
| Last modified on | 2026/02/25 15:00:04 |
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Basic information
Public title
Effects of Nostoc commune hot-water extract intake on salivary IgA in healthy adults
Acronym
Ishikurage-IgA Study
Scientific Title
Effects of hot-water extract of edible cyanobacteria Nostoc commune on salivary secretory IgA: a randomized crossover trial
Scientific Title:Acronym
NOSTOC-sIgA Trial
Region
| Japan |
Condition
Condition
Healthy adults (mucosal immunity assessment)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of hot-water extract of edible cyanobacteria Nostoc commune on salivary secretory immunoglobulin A (sIgA) levels in healthy adults using a randomized crossover design. This study aims to assess mucosal immune responses and explore the potential of Nostoc commune as a functional food material.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in salivary secretory immunoglobulin A (sIgA) concentration measured at baseline and 10, 30, 60, 90, and 120 minutes after intake
Key secondary outcomes
Lifestyle questionnaire including smoking, alcohol intake, and physical activity
Sleep status assessed using the Japanese version of the Pittsburgh Sleep Quality Index (PSQI)
Adverse events monitoring
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants ingest 100mL of a beverage made by extracting 1g of Nostoc with 100mL of hot water. After an overnight fast, salivary samples are collected repeatedly up to 120 minutes post-intake. A 6-day washout period is applied before crossover to the control condition.
Interventions/Control_2
Participants ingest 100 mL of water as the control beverage under identical conditions. Saliva is collected repeatedly under the same protocol, followed by crossover after a 6-day washout period.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older
Students or staff at Kitasato University Sagamihara campus
Provided written informed consent
Key exclusion criteria
Allergy to Nostoc commune components
Fever 37.5 C or higher
Regular medication use
Immunodeficiency anticoagulant therapy or significant underlying disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | GO |
| Middle name | |
| Last name | MUTO |
Organization
Kitasato University
Division name
Department of Hygiene and Public Health, School of Medicine
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
080-5912-7446
gomuto@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | GO |
| Middle name | |
| Last name | MUTO |
Organization
Kitasato University
Division name
Department of Hygiene and Public Health, School of Medicine
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
08059127446
Homepage URL
gomuto@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato 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
Research Ethics Committee of the Kitasato University School of Medicine
Address
1-15-1 Kitasato, Minami-ku Sagamihara
Tel
0427788111
rinrib@med.kitasato-u.ac.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
| 2026 | Year | 02 | Month | 28 | 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
| 2026 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2028 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a randomized crossover nutritional intervention trial evaluating physiological responses to a food component and does not involve investigational medicinal products.
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069476
