The Effect of a Test Diet on Immune Function in Healthy Men - Single-Arm, Open-Label Trial

UMIN ID: UMIN000050569

Registered date:27/04/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2023/03/30
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Take sixteen tablets a day, once or twice daily.

Outcome(s)

• Primary Outcome: immunological parameters

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 50years-old
• Gender: Male
• Exclude criteria: 1. Currently receiving any medical treatment with drugs or Chinese herbs. Medications used as needed are acceptable. 2. Receive diet or exercise therapy under medical supervision. 3. Have serious illnesses or a history of serious illnesses. 4. Have immune disorders such as atopic dermatitis, allergic rhinitis, bronchial asthma, and chronic bronchitis. 5. Voluntarily consume yogurt or beverages containing lactic acid bacteria and bifidobacteria more than three times a week. 6. Have been taking foods or dietary supplements with functional health claims that affect the outcome of the study more than three times per week. 7. Be vaccinated against influenza viruses or SARS-CoV-2 within one month before the first study visit, or have the plan to be vaccinated during the study. 8. Have allergies to drugs or foods. 9. Workers on night shifts or with irregular work schedules. 10. Who plans for significant changes in lifestyle, such as eating habits, sleep duration, or exercise habits. 11. Alcohol drinking over an average of 40g/day per week. 12. Who plans to travel abroad during the study period. 13. Have above 200 mL blood donation within one month before the start period of the study, or have above 400 mL blood donation within three months before the start period of the study. 14. Those who have participated in other clinical trials within one month before enrolling in the study, those who are currently participating in other clinical trials, and those who plan to participate in other clinical trials after enrolling in the study. 15. Who are unsuitable for the study, as determined by the investigator.

Related Information

• Primary Sponsor: IMEQRD Co., Ltd
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.