UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056841
Receipt number R000064960
Scientific Title The Effect of Hot Water Extract of Edible Cyanobacteria Ishikurage (Nostoc commune) on Salivary Secretory IgA
Date of disclosure of the study information 2025/10/01
Last modified on 2025/01/27 20:45:35

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Basic information

Public title

The Effect of Hot Water Extract of Edible Cyanobacteria Ishikurage (Nostoc commune) on Salivary Secretory IgA

Acronym

The Immune-Boosting Effects of Ishikurage Extract

Scientific Title

The Effect of Hot Water Extract of Edible Cyanobacteria Ishikurage (Nostoc commune) on Salivary Secretory IgA

Scientific Title:Acronym

The Immune-Boosting Effects of Ishikurage Extract

Region

Japan


Condition

Condition

healthy

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Increases in Immunoglobulin A Levels

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Salivary Secretory IgA Levels Increase After Consumption of Ishikurage Extract

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

Prevention

Type of intervention

Food

Interventions/Control_1

Hot Water Extract of Ishikurage (Nostoc commune)

Interventions/Control_2

water

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 Aged 20 and Over

Key exclusion criteria

Individuals Who Are Pregnant or Breastfeeding, Have Chronic Diseases, or Are 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

Email

ryoryo2003@yahoo.co.jp


Public contact

Name of contact person

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

Homepage URL


Email

ryoryo2003@yahoo.co.jp


Sponsor or person

Institute

MATSUMOTO UNIVERSITY

Institute

Department

Personal name



Funding Source

Organization

Microalgae 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

Email

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



Other administrative information

Date of disclosure of the study information

2025 Year 10 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 27 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 27 Day

Last modified on

2025 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064960