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Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects

Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects - Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054716
Enrollment
60
Registered
2025-06-20
Start date
2024-06-21
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

Male/female adults

Interventions

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women aged 20 to below 35 years at the time of consent acquisition. 2. Subjects with a Body Mass Index (BMI) less than 30.0 kg/m2. 3. Non-smokers (no smoking in the past year). 4. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion criteria: 1. Subjects unable to adhere to the trial protocol during the study period. 2. Subjects consuming Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health supplements (including supplements) that affect the autonomic nervous system, metabolism, and sleep, and cannot discontinue use during the study period. 3. Subjects taking medications or quasi-drugs that affect the autonomic nervous system, metabolism, and sleep, and cannot discontinue use during the study period. 4. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials at the time of consent acquisition. 5. Subjects who have experienced significant life changes such as moving, changing jobs, or separation from close relatives within the last three months prior to consent acquisition, which could lead to high stress, or those likely to experience such events during the study period. 6. Subjects with irregular life rhythms (including those with highly irregular meal times, shift workers, night workers, etc.). 7. Subjects who engage in excessive physical exercise routinely. 8. Subjects with excessive alcohol intake. 9. Subjects with severe symptoms of Premenstrual Syndrome (PMS). 10. Subjects with a current or past history of drug or alcohol dependence. 11. Subjects with allergic rhinitis that may interfere with trial operations. 12. Subjects under medical supervision for dietary or exercise therapy. 13. Subjects currently receiving treatment for, or with a history of, mental disorders (such as depression) or sleep disorders.

Design outcomes

Primary

MeasureTime frame
Psychological Questionnaire

Secondary

MeasureTime frame
Heart Rate

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-6225-9001

Outcome results

None listed

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