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A Study on the Effect of Plant-Derived Products on Mucosal Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Study on the Effect of Plant-Derived Products on Mucosal Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Study on the Effect of Plant-Derived Products on Mucosal Immune Function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042653
Enrollment
60
Registered
2020-12-04
Start date
2020-12-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females aged 20 to 64 years-old. (2)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: Subjects (who) (1)have never had an upper respiratory tract infection or viral gastroenteritis in the last two winters. (2)have a faster salivary sIgA secretion rate. (3)contract diseases (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease). (4)have a chronic disease and regularly use medications. (5)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions. (6)can't stop taking foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, and/or live bacteria during test periods. (7)regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides. (8)get intense exercises (e.g., muscle training in the gym) more than 3 times a week. (9)are under treatment for periodontal disease. (10)used antibiotics within the last two weeks prior to the screening. (11)can't stop drinking from 2 days before each measurement. (12)have declared allergic reaction to ingredients of test foods. (13)have a history of and/or contract pollinosis and/or allergic rhinitis. (14)have a history and/or a surgical history of digestive disease affecting digestion and absorption. (15)plan to become pregnant after informed consent, pregnant or lactating. (16)are judged unsuitable for the study by the screening. (17)have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last 3 months prior to the study. (18)are under treatment for or have a history of drug addiction and/or alcoholism. (19)are shiftworker, midnight-shift worker and/or teleworker. (20)are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the study. (21)are judged unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
salivary sIgA

Secondary

MeasureTime frame
Incidence of symptoms of the common cold

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026