Evaluation of fermented royal jelly on immune parameters -Placebo-controlled randomized, double-blind study

Not Applicable

• Conditions: Adult

• Registration Number: JPRN-UMIN000045450
• Lead Sponsor: KSO Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-10
• Study Completion: 2021-11-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who have current or history of food allergies or asthma. 2. Subjects who have a seasonal or perennial allergies during clinical study period. 3. Subjects who have a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on. 4. Subjects with a current or history of serious illness, such as diabetes, liver disease, kidney disease, heart disease, and more 5. Subjects who have taken medication treatment or going to receive medication. 6. Subjects who are going to receive vaccination for influenza during clinical study period. 7. Subjects who have a history of salivary gland disease, Sjogren's syndrome, perioral radiation therapy, or whole blood dialysis. 8. Subjects who regularly use dietary supplements and health foods (including foods for specified health uses and foods with functional claims) that may affect immunity. 9. Subjects who can not continue regular life. 10. Subjects who have an irregular habit because of working at night or working under work-shift form. 11. Subjects with smoking habit. 12. Subjects who are going to go abroad during clinical study period. 13. Subjects who have taken the blood sampling either 200 mL within 4 weeks or 400 ml within 3 months at the time of clinical examination of screening. 14. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 15. Subjects who are planning to participate and/or had participated in other clinical studies within 3 months prior to the current study. 16. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified