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A study to confirm the effect of test food on improving human immune function. -Open Study-

A study to confirm the effect of test food on improving human immune function. -Open Study- - A study to confirm the effect of test food on improving human immune function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046578
Enrollment
20
Registered
2022-01-10
Start date
2022-01-10
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

Healthy adults

Interventions

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Males and females from 20 to 64 years of age at the time of consent to participate in this study. 2. Subjects who know they are prone to catching a cold. 3. Subjects who do not plan to inoculate vaccines such as COVID-19 or influenza virus during the research period. 4. Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who are suffering from, undergoing treatment for, or with a history of serious diseases such as diabetes, kidney / liver disease, heart disease or thyroid disease, adrenal disease, and other metabolic diseases. 2. Subjects who have chronic diseases and take medication on a daily basis. 3. Subjects who regularly use medicines (e.g., Antihistamine, antiallergics, Nasal spray and Common cold medicines) or food for specified health use or Food with functional claims or health food that may affect immune function. 4. Subjects who are not able to stop taking foods rich in lactic acid bacteria and bifidobacterial, or lactic acid bacteria preparations or supplements. 5. Subjects who consistently drink more than the appropriate amount of alcohol (about 20 g of pure alcohol per day). 6. Subjects who can't stop drinking from 2 days before each test. 7. Subjects who have food allergy. 8. Subjects engaged in day and night shift work or Physical labor such as transporting heavy objects. 9. Subjects with digestive diseases affecting digestion and absorption and Subjects with a history of digestive surgery. (excluding appendicitis) 10. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 11. Subjects who are judged to be inappropriate as research subjects by blood tests in screening tests. 12. Subjects who have a history or current condition of drug or alcohol dependence. 13. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate. 14. Subjects who plan to travel abroad, including overseas travel, during this research period. 15. Subjects who has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or donated blood components. 16. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.

Design outcomes

Primary

MeasureTime frame
pDC activity

Secondary

MeasureTime frame
Salivary sIgA (concentration, secretion rate, secretion amount) CD56 / CD16 (NK cells) Physical condition Questionnaire QOL questionnaire

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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