Verification study on the effect of test food intake on immune function

UMIN ID: UMIN000049824

Registered date:21/12/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2022/12/22
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

8-weeks intake of the test food
8-weeks intake of the placebo food

Outcome(s)

• Primary Outcome: NK cell activity
• Secondary Outcome: Blood immune index

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who regularly use the foods rich(yogurt, lactobacillus drinks, cheese, kimchi, pickles, etc.) in lactic acid bacteria, health foods and medicines at least 3 times a week. 2. Subjects who are currently receiving medication or outpatient treatment for some serious disease. 3. Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician. 4. Subjects who may develop allergies to the test food. 5. Subjects who have a current or a history of drug dependence or alcohol dependence. 6. Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 7. Subjects who have irregular rhythm of life due to night work or shift work. 8. Subjects who are with extremely irregular eating, sleeping, or other habits. 9. Subjects who have an extremely unbalanced diet. 10. Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases. 11. Subject who use health foods and medicines that contain ingredients that affect immune function. 12. Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period. 13. Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent. 14. Subjects who are currently pregnant or breastfeeding. or who are likely to become so during the study period. 15. Subjects who have difficulty in complying with the recording of various questionnaires. 16.Subjects who are judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR.

Related Information

• Primary Sponsor: M&I Science CORP.
• Source(s) of Monetary Support: Nissin York Co., Ltd.