Healthy adults
Conditions
Interventions
High-dose test food ingestion for 12 consecutive weeks
Medium-dose test food ingestion for 12 consecutive weeks
Low-dose test food ingestion for 12 consecutive weeks
Placebo ingestion for 12 consecuti
Sponsors
FANCL Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese male and female participants, 40 to 69 years of age. 2. POMS2-AS T score of Fatigue-Inertia >=50, and Vigor-Activity <=50. 3. Relatively high percentage of CD8+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity. 4. Have ability to consent.
Exclusion criteria
Exclusion criteria: 1. Undergone surgical resection of the gastrointestinal tract (Not including appendectomy). 2. Have disease that requires constant medication, or those have a serious medical history that requires medication. 3. Having or had treatment for or diagnosed as autoimmune diseases. 4. Having or had mental illness, chronic fatigue syndrome or sleep disturbance. 5. Diagnosed or suspected as sleep apnea syndrome. 6. Under sleep, stress, and/or fatigue treatment. 7. Night and day shift worker or manual laborer. 8. Regularly taking or planning to take medicine, supplements, FOSHU, and/or food which may affect the results during the study. 9. Possible allergic response related to the study. 10. Is or expected to be pregnant, breastfeeding or desiring to be pregnant during the study period. 11. Excessive drinking habits. 12. Planning to travel abroad during the study period, or planning to go on domestic business trips or domestic trips for more than 7 consecutive days during the study period. 13. Participating in other clinical studies at the beginning of the present study. 14. Judged by the investigator to be inappropriate candidates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T scores of the Profile of Mood States 2nd Edition Adult Short Form (POMS2-AS) (Japanese version) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunosenescence markers, Anti-Aging QOL Common Questionnaire, MOS 36-Item Short-Form Health Survey version 2 acute version (Japanese version), Pittsburgh Sleep Quality Index (Japanese version) | — |
Countries
Japan
Contacts
Public ContactReiko Naito
Kenkoin Medical Corporation Foundation Kenkoin Clinic
Outcome results
None listed