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

Examination of the efficacy of Shiitake continuous administration on the immune responses -A exploratory randomized parallel-group trial- - The continuous administration exploratory randomized parallel-group trial of Shiitake

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053926
Enrollment
30
Registered
2024-03-22
Start date
2024-01-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Shiitake None

Sponsors

University of Tsukuba, Institute of Medicine
Lead Sponsor
E-sport Co., Ltd Ohsyo Shiitake Co., Ltd National agriculture and food research organization, food research institute
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women between the ages of 18 and 64 years old at the time of consent. 2. Subjects who have had common cold-like symptoms with one or more episodes of fever at least one year prior to obtaining consent. 3. Subjects who have been properly informed about the participation in this study, and who have given written consent of their own free will with full understanding.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
HLA-DR, CD40, CD86 expression levels of conventional DC (cDC), plasmacytoid DC (pDC) and monocytes (Multi-color flow cytometry analysis)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKoichi Hashimoto

University of Tsukuba, Institute of Medicine Clinical and translational research methodology

koichi.hashimoto@md.tsukuba.ac.jp029-853-3064

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026