Effects of consumption of the test food on immune function in healthy Japanese

UMIN ID: UMIN000056125

Registered date:12/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/11/12
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Eight weeks The test food Administration: Four capsules/pack/day
Duration: Eight weeks Placebo Administration: Four capsules/pack/day

Outcome(s)

• Primary Outcome: Major immune related marker
• Secondary Outcome: <Important secondary outcomes> Physical condition questionnaire <Other secondary outcomes> Secondary immune related markers and quality of life (QOL) index

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, anemia, or any other chronic diseases 4. Individuals who have autoimmune disease 5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. Individuals who are taking or using medications (including herbal medicines) or supplements, particularly those who regularly use warfarin, rhinitis medicines, or antihistamines 7. Individuals who use immunosuppressants such as steroid 8. Individuals who are allergic to medicines or foods 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. Individuals who have pollen allergy or perennial allergic rhinitis 11. Individuals who are smokers or have quit smoking within the last year before the agreement to participate in this study 12. Individuals who drink alcoholic beverages excessively 13. Individuals who are on a diet 14. Individuals who engage in intense exercise 15. Individuals who have an irregular lifestyle due to shift work or other reasons 16. Individuals who have received vaccinations for the purpose of preventing infectious diseases within the three months before the agreement to participate in this study, or who are scheduled to receive vaccinations during this study 17. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 18. Individuals who are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: Euglena Co., Ltd.