Healthy participants
Conditions
Interventions
4-week intake of test foods
4-week intake of placebo foods
Sponsors
Macromill, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged between 20 and 64 years at the time of obtaining informed consent. 2. Healthy Japanese men and women. 3. Individuals who feel socially isolated and/or lonely. 4. Individuals who have the capacity to consent, have received sufficient explanation regarding the purpose and content of the study, have fully understood the information, and voluntarily agreed to participate by providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals receiving medical treatment for psychiatric disorders or autonomic nervous system disorders, or those scheduled to receive such treatment or medication during the study period. 2. Individuals with chronic diseases who are receiving medical treatment. 3. Individuals with a serious past history of cerebrovascular, cardiac, hepatic, renal, hematological, or endocrine diseases. 4. Individuals with a serious past history of gastrointestinal diseases. 5. Individuals judged by the principal investigator to have a psychiatric disorder based on the score of SDS. 6. Individuals with a history of feeling unwell or experiencing health deterioration due to blood collection. 7. Individuals who may develop an allergic reaction to the test food. 8. Men or women who donated 200 mL of blood within 4 weeks or component blood within 2 weeks prior to the on-site screening test; women who donated 400 mL of blood within 16 weeks prior to the screening; or men who donated 400 mL of blood within 12 weeks prior to the screening. 9. Smokers. 10. Habitual alcohol consumers. 11. Individuals with extremely irregular sleep patterns or dietary habits. 12. Individuals who cannot discontinue the intake of Foods for Specified Health Uses (FOSHU), Foods with Function Claims, or other health foods during the study period. 13. Individuals who are expected to experience major changes in living environment, or significant changes in dietary or exercise habits during the study period. 14. Women who are breastfeeding, pregnant, possibly pregnant, or planning to become pregnant during the study period. 15. Individuals currently participating in another clinical trial, those who have participated in another clinical trial within 4 weeks prior to the on-site screening test, or those planning to participate in another clinical trial during the study period. 16. Any other individuals judged by the principal investigator to be inappropriate as study participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UCLA Loneliness Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) SF-36v2 Japanese version (2) WHO-DAS2.0 (3) Serum serotonin, serum oxytocin (4) Daily step count | — |
Countries
Japan
Contacts
Public ContactYumi Kimoto
Macromill, Inc. Clinical Trial Department, Life Science Division
Outcome results
None listed