Examination of the efficacy of Shiitake continuous administration on the immune responses

UMIN ID: UMIN000053926

Registered date:22/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2024/01/09
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Shiitake
None

Outcome(s)

• Primary Outcome: HLA-DR, CD40, CD86 expression levels of conventional DC (cDC), plasmacytoid DC (pDC) and monocytes (Multi-color flow cytometry analysis)
• Secondary Outcome: 1. Physical condition (common cold-like symptoms) 2. body temperature 3. Mood profile (POMS2 short version) 4. Salivary IgA 5. NK cell activity 6. Adverse events 7. Multicolor flow cytometry analysis of immune cells in peripheral blood

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1.Subjects who are currently undergoing hospitalization or drug treatment for any disease. 2. Subjects with a history of shiitake mushroom dermatitis. 3. Subjects who cannot consume dried shiitake mushrooms due to taste. 4. Subjects who have a serious systemic disease. 5. Subjects with a history of autoimmune diseases. 6. Subjects who are currently using over-the-counter drugs, quasi-drugs, food for specified health uses, functional foods, supplements, etc. on a regular basis. 7. Subjects who work in shifts. 8. Subjects whose lifestyle (diet, sleep, exercise, etc.) is likely to change significantly during the research period. 9. Pregnant women or those of reproductive potential who are unable to use contraception during the research period. 10. Subjects with food allergies 11. Other subjects deemed inappropriate by the principal investigator.

Related Information

• Primary Sponsor: University of Tsukuba, Institute of Medicine
• Secondary Sponsor: E-sport Co., Ltd Ohsyo Shiitake Co., Ltd National agriculture and food research organization, food research institute
• Source(s) of Monetary Support: Ministry of Agriculture, Forestry and Fisheries