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Functionality verification test by continuous intake of test food

Functionality verification test by continuous intake of test food: a randomized, double blind, placebo-controlled study - Functionality verification test by continuous intake of test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058384
Enrollment
70
Registered
2025-07-08
Start date
2025-07-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Continuous intake of one packet per day of the test food for 12 weeks. Continuous intake of one packet per day of the placebo for 12 weeks.

Sponsors

Japan Clinical Trial Association
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Males and females aged of 40-59 years 2.Subjects who often feel tired in their daily lives and those who feel easily fatigued. 3.Subjects who feel that they catch colds easily or get sick easily. 4.Subjects who are able to maintain the daily routine they had before participating in this test. 5.Have obtained written consent to participate in this study of their own free will, based on a thorough understanding of the study.

Exclusion criteria

Exclusion criteria: 1. Subjects who are currently receiving medical treatment or rprescription medication for chronic fatigue or chronic fatigue syndrome. 2. Subjects with a serious disease. 3. Pregnant, lactating, or planning to become pregnant during the study period 4. Subjects who are receiving medical treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) under the supervision of a physician 5. Subjects who are taking or have taken supplements, functional foods, or medicines that affect the immune system 6. Subjects who take or will take new supplements, functional foods, or medicines that affect immunity, sleep, body fat, or skin during the study period. 7. Subjects with food allergies. 8. Subjects with a history of drug dependence 9. Excessive smokers and excessive alcohol users 10. BMI less than 18.5 or more than 31 11. Subjects who plan to receive any vaccination from 30 days prior to the start of the study through the end of the study period. 12. Subjects who work night shift or rotating day and night shifts. 13. Subjects who have participated in other clinical trials within the past month and those who are scheduled to participate during the study period. 14. Subjects who are deemed inappropriate by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Saliva tests ( s-IgA, cortisol, oxytocin, DHEA), Body weight and body fat, OSA sleep inventory MA version, VAS, skin image analysis (wrinkles, blemishes, texture), subjective evaluation

Countries

Japan

Contacts

Public ContactTakeshi Kaneko

Japan Clinical Trial Association N.A.

info@yakujihou.org0364574666

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026