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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2022
INTERVENTION: Duration: 12 weeks Test food: Nucleotide containing capsule Administration: Take two capsules per day at breakfast with water *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: 12 weeks Test food: Placebo capsule Administration: Take two capsules per day at breakfast with water *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. CONDITION: Healthy Japanese subjects PRIMARY OUTCOME: 1. The cumulative number of onset days with common cold symptoms per subject SECONDARY OUTCOME: 1. The maximum duration of the days with common cold symptoms per subject; ; 2. The cumulative number of onset days and the maximum duration of the days with whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, muscle pain, and headache per subject; ; 3. The cumulative number of onset days with common cold symptoms, whole body malaise, chilliness, feverishness, fatigue, sneezing, nasal discharge, blocked nose, throat pain, cough, joint pain, muscle pain, and headache per group; ; 4. Scoring of immunological vigor at 12 weeks after consumption (12w); ; 5. Immunological grade at 12w; ; 6. T lymphocyte age (upper limit and lower limit) at 12w; ; 7. Scoring of following items: number of T cells, number of CD8+CD28+ T cells, CD4+T cells / CD8+T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, and number of natural killer (NK) cells at 12w; ; 8. Number of T cells, CD4+ T cells / CD8+ T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, number of NK cells, number of CD8+CD28+ T cells, number of CD4+ T cells, number of CD8+ T cells, number of memory T cells, percentage of T cells, percentage of CD4+ T cells, percentage of CD8+ T cells, percentage of naive T cells, percentage memory T cells, percentage of CD56+16‐ NK cells, percentage of CD56+16+ NK cells, percentage of B cells, percentage of CD8+CD28+ T cells, secretary immunoglobulin A (sIgA) in the saliva, and NK cell activity at 12w INCLUSION CRITERIA:
Epistemonikos ID: 0abbdb0d83e0d634e86f568602c27e7f619f206f
First added on: Aug 26, 2024