Effect of the test food intake on immunosenescence markers in healthy participants: A randomized, placebo controlled, double blind, parallel group study

Recruitment & Eligibility

Status: Complete: follow-up continuing

Sex: All

Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

1. Participants who undergone surgical resection of the gastrointestinal tract (Not including appendectomy). 2. Participants who have disease that requires constant medication, or those have a serious medical history that requires medication. 3. Participants with autoimmune diseases or a history of autoimmune diseases. 4. Participants with mental illness, chronic fatigue syndrome, insomnia, or a history of such illnesses. 5. Participants who diagnosed or suspected as sleep apnea syndrome. 6. Participants undergoing treatment related to sleep, stress, and/or fatigue. 7. Night and day shift worker or manual laborer. 8. Participants who regularly taking or planning to take medicine, supplements, FOSHU, and/or food which may affect the results during the study. 9. Participants having possibilities for emerging allergy relates to the study. 10. Heavy drinkers of alcohol or excessive smokers. 11. Participants who are planning to travel abroad during the study period, or who are planning of long-term domestic trip for more than one week in study period. 12. Participants who are judged as unsuitable for the study based on the results of lifestyle questionnaire. 13. Participants who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function. 14. Participants whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range. 15. Participants who are Participating in other clinical studies at the beginning of the present study. 16. Participants who are becoming pregnant or intend to become pregnant. 17. Participants judged as unsuitable for the study by the investigator for other reasons.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunosenescence markers ; percentage of CD8+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity.

Secondary Outcome Measures

Name	Time	Method
Other immunosenescence markers ; CD3+ T cells / lymphocyte ratio, CD4+ T cells / lymphocyte ratio, CD8+ T cells / lymphocyte ratio, CD4+ T cells / CD8+ T cells ratio, percentage of CD4+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity, naive T cells / CD4+ T cells ratio, central memory T cells / CD4+ T cells ratio, effector memory T cells / CD4+ T cells ratio, TEMRA T cells / CD4+ T cells ratio, PD-1+ / CD4+ T cell ratio, naive T cells / CD8+ T cells ratio, central memory T cells / CD8+ T cells ratio, effector memory T cells / CD8+ T cells ratio, PD-1+ / CD8+ T cell ratio