Effects of consumption of the test food on the immune function in healthy Japanese subjects: an open-label trial
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000048135
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 17
Not provided
Subjects (who/whose) 1.undergoing medical treatment or having a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an ICD 3.undergoing treatment for chronic diseases such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, or hypertension 4.take "Foods for Specified Health Uses," or "Foods with Functional Claims" on daily 5.usually taking medicines (including herbal medicines) or supplements 6.are allergic to medicines or the test food related products 7.are pregnant or lactation / become pregnant 8.have COVID-19 9.have been enrolled in other clinical trials within the last 3 months before the agreement to participate in this trial or plan to participate in another trial during this trial 10.judged as ineligible to participate in the study by the physician 11.working hours are irregular 12.have irregular ifestyles (such as diet, and exercise) 13.sleep habits are irregular 14.usually sleeping less than 6 hours / will sleep less than 6 hours during the test period on daily 15.live with their infants less than one year old 16.sleep with their children (1 to 6 years old) 17. live with requiring long-term care persons 18.sleep with more than one person 19. have nocturia three times or more 20.drink to excess (average of more than about 20 g/day as absolute alcohol intake) 21.take food/beverage containing functional ingredients that may influence immune function, sleep quality, or subjective fatigue/stress 22.have autoimmune disease 23.taking immunosuppressants 24.have perennial allergic rhinitis 25.undergoing treatment for sleep disorder such as insomnia or sleep apnea syndrome 26.smoke 27.have medical history of dermatitis, hypotension, atopy, bronchial asthma, cardiopathy, organ transplantation, psychiatric disorder, HIV/AIDS, short bowel syndrome, arteriosclerosis, histoplasmosis, hypercalcemia, lymphoma, sarcoidosis, or tuberculosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method