Effects of consumption of the test food on psychological stress in healthy Japanese

UMIN ID: UMIN000053962

Registered date:25/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/03/25
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

<Duration> Three days <Test food> Period I: Active food Period II: Placebo food *The intervention sequence is Period I to Period II. *Washout period is for one week or more
<Duration> Three days <Test food> Period I: Placebo food Period II: Active food *The intervention sequence is Period I to Period II. *Washout period is for one week or more

Outcome(s)

• Primary Outcome: 1. The Profile of Mood States 2nd Edition (POMS2)
• Secondary Outcome: 1. Saliva test

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 60years-old
• Gender: Male
• Exclude criteria: Individuals who 1. are under medical treatment or have a medical history of malignant tumor, heart failure, and/or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are under treatment for any of cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes, dyslipidemia, hypertension, or other chronic diseases 4. are under medical treatment for chronic fatigue syndrome or menopausal syndrome 5. take "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. take/use medications, herbal medicines, and supplements 7. are allergic to medications and/or the test food related products (particularly fish, type I collagen, and gelatin) 8. have been enrolled in other clinical studies within the last 28 days before agreeing to participate or plan to participate another study during the study 9. are good at or like calculation work (such as using calculator, playing Sudoku, or what the participants consider to be calculation work) 10. have a final education in the sciences 11. take collagen/gelatin-rich foods at least 2 days (2 servings) a week 12. work in physical labor (such as transporting heavy objects) 13. live with requiring long-term care persons 14. live with infants (age <1) 15. sleep in the same room with children aged 1~5 16. sleep with more than one person (except when two mattresses are combined) 17. have irregular sleeping time or habit (sleeping more than two hours different from usual bedtime by at least two days a week) due to work such as a late-night shift 18. have nocturia three times or more from 22:00 to 3:00 the next day 19. drink to excess (average of more than about 20 g/day as absolute alcohol intake) every day 20. take foods or use daily use items with a relaxing effect 21. are judged as ineligible to participate by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic National University Corporation UTSUNOMIYA UNIVERSITY
• Source(s) of Monetary Support: ORTHOMEDICO Inc.,Nippi, Incorporated