A verification study of the immunostimulatory effects

UMIN ID: UMIN000052919

Registered date:21/11/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2023/11/27
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: Four weeks Test food
Duration: Four weeks Placebo food

Outcome(s)

• Primary Outcome: 1. The cumulative number of onset days with common cold-like symptoms* during the intervention period per participant * The common cold-like symptom is defined as the onset of more than one of the following symptoms in the diary: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, nasal congestion, throat pain, cough, joint pain, and muscle pain.
• Secondary Outcome: 1. The maximum duration of the days with common cold-like symptoms* during the intervention period per participant 2. The measured value of the total immunoglobulin A (IgA) in the stool at four weeks after consumption (4w) 3. The measured values of scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit and lower limit), percentage of CD3+T cells, number of CD3+T cells, scoring of number of CD3+T cells, percentage of CD4+T cells, number of CD4+T cells, percentage of CD8+T cells, number of CD8+T cells, CD4+T cells / CD8+T cells ratio, scoring of CD4+T cells / CD8+T cells ratio, percentage of naive T cells, number of naive T cells, scoring of number of naive T cells, percentage of memory T cells, number of memory T cells, naive T cells / memory T cells ratio, scoring of naive T cells / memory T cells ratio, percentage of CD56+16-natural killer (NK) cells, percentage of CD56+16+NK cells, number of NK cells, scoring of number of NK cells, percentage of B cells, number of B cells, scoring of number of B cells, percentage of CD8+CD28+T cells, number of CD8+CD28+T cells, and scoring of number of CD8+CD28+T cells at 4w 4. The measured values of vitality, appetite, skin condition measured by visual analog scale (VAS) at 4w * The common cold-like symptom is defined as the onset of more than one of the following symptoms in the diary: whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, nasal congestion, throat pain, cough, joint pain, and muscle pain.

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, and 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 medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test food related products (particularly salmon or gelatin) 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 another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician 10. Individuals who have received vaccination for infectious diseases such as influenza within the last three months

Related Information

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