The effects of test food intake on immune function

UMIN ID: UMIN000050586

Registered date:23/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2023/03/27
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of test food for 4 weeks
Ingestion of placebo food for 4 weeks

Outcome(s)

• Primary Outcome: Immunity evaluation, Common cold symptoms survey Subjective indicators of health-related quality of life

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 49years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects with heart, liver, and kidney diseases (including complications of other diseases) (2) Subjects with a history of cardiovascular disease (3) Subjects with diabetes (4) Subjects with diseases currently being treated (5) Subjects with abnormal cardiac function (6) Subjects with autoimmune disease (7) Subjects taking warfarin (8) Subjects using immunosuppressive agents such as steroids (9) Subjects who are allergic to food and drugs (10) Subjects with anemia symptoms (11) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (12) Those who play intense sports and subjects who are on a diet (13) Subjects with extremely irregular eating habits (14) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (15) Subjects who drink more than 60 g of average daily pure alcohol (16) Subjects who smoke an average of 21 or more cigarettes a day (17) Subjects with irregular lives such as shift workers (18) Subjects who are participating in or will participate in other clinical trials at the start of this study. (19) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Related Information

• Primary Sponsor: Miura Clinic, Medical Corporation Kanonkai
• Source(s) of Monetary Support: Euglena Co.,Ltd.