The effects on immune function

UMIN ID: UMIN000055614

Registered date:25/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/09/25
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Eight weeks Test food: Oryza Ceramide (R)-PCD Administration: Take one capsule per day after breakfast. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Eight weeks Test food: Placebo Administration: Take one capsule per day after breakfast. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

• Primary Outcome: 1. The measured value of immunoglobulin A (IgA) in the stool at eight weeks after consumption (8w)
• Secondary Outcome: 1. The measured value of IgA in the stool at four weeks after consumption (4w) 2. The logarithmic value of IgA in the stool at 4w and 8w 3. The measured value and logarithmic value of secretory IgA (sIgA) in the saliva at 4w and 8w 4. The cumulative number of days with common cold symptoms and each symptom (rhinorrhea / nasal discharge: yellow secretion, rhinorrhea / nasal discharge: bloody secretion, nasal congestion, sneezing, sore throat, hoarseness, cough, headache, malaise, muscle pain, diarrhea, nausea, vomiting) during this study period per individual 5. The measured values of acetic acid, propionic acid, iso-butyric acid, n-butyric acid, iso-valeric acid, n-valeric acid, lactic acid, succinic acid, and formic acid at 4w and 8w

Key inclusion & exclusion criteria

• Age minimum: 18years-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, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and foods related to the test food 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. 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 9. Individuals who have received vaccination for influenza within the last three months 10. 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: Oryza Oil & Fat Chemical Co., Ltd.