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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056236
Enrollment
70
Registered
2024-11-22
Start date
2024-11-23
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 are aware of tendency to upper respiratory infections. 3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: Subjects(who) 1) contract, are under treatment for or have a history of serious diseases (e.g., diabetes, kidney/liver disease, heart disease, thyroid disease, adrenal disease and/or metabolic disease). 2) have a chronic disease and regularly use medications. 3) contract pollinosis, allergic rhinitis, atopic dermatitis, bronchial asthma, or chronic bronchitis. 4) have a history and/or a surgical history of digestive disease affecting digestion and absorption. 5) can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber during this study. 6) can't stop using supplements and/or functional foods (including Foods with Function Claims) affecting immune functions. 7) are smokers. 8) have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent. 9) have declared allergic reaction to ingredients of test foods. 10) can't stop drinking from 2 days before each measurement. 11) are under treatment for or have a history of drug addiction and/or alcoholism. 12) are shiftworker, midnight worker and/or physical labor. 13) are judged as unsuitable for the study by blood tests in screening test. 14) plan to become pregnant after informed consent, pregnant or lactating. 15) have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the screening test. 16) have a habit of strenuous exercise such as running or soccer. 17) are planning to go abroad, such as on an overseas trip. 18) have used drugs (including antiallergic drugs and antibiotics) that are thought to affect immune function within 2 weeks prior to the screening test. 19) are planning to participate and/or had participated in other clinical studies within the last 1 month prior to the current study. 20) are judged unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
cDC activity after 8 weeks consumption Physical condition questionnaire up to 8 weeks consumption

Secondary

MeasureTime frame
cDC-related immune marker after 8 weeks consumption

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Clinical Trial Management department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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