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Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals. -A randomized, placebo-controlled, double-blind, parallel-group comparison study -

Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals. -A randomized, placebo-controlled, double-blind, parallel-group comparison study - - Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053429
Enrollment
140
Registered
2024-02-02
Start date
2024-02-03
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) Healthy males and females aged 20 to 64 years-old. 2) Subjects who have reported being susceptible to colds and influenza and have had upper respiratory infections within the past two years. 3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: Subjects(who) 1. have serious illnesses such as diabetes, kidney and liver diseases, heart diseases, thyroid diseases, adrenal diseases, other metabolic diseases, those who are undergoing treatment, and those with a medical history. 2. have a chronic disease and regularly use medications. 3. with hay fever, atopic dermatitis, bronchial asthma, and chronic bronchitis. 4. contract or have a surgical history of digestive disease affecting digestion and absorption. 5. have been diagnosed as dry mouth. 6. have dental or oral problems accompanied by bleeding (such as canker sores). 7. have received dental treatment or dental checkups within 24 hours prior to the screening test date, or willing to receive dental treatment or dental checkups within 24 hours prior to each examination. 8)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions 9. are unable to stop taking supplements and health foods (including functional foods) that may affect their immunity. 10. have an excessive drinking habit of more than approximately 60 grams of pure alcohol per day and who consume more than 20 grams of alcohol per day during the study period. 11. are unable to abstain from alcohol for 2 days before each examination, including the screening test. 12. have declared allergic reaction to ingredients of test foods. 13. smoke 21 or more cigarettes a day. 14. are under treatment for or have a history of drug addiction and/or alcoholism. 15. are shift worker and/or midnight-shift worker. 16. to 22. are listed in the "Other related information" column.

Design outcomes

Primary

MeasureTime frame
Major immune markers

Secondary

MeasureTime frame
questionnaire (Physical condition, QOL) Other immune markers

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