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Clinical Study of Psychological Impact of Food Ingredients -(9)

Clinical Study of Psychological Impact of Food Ingredients -(9) - Clinical Study of Psychological Impact of Food Ingredients -(9)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049386
Enrollment
30
Registered
2023-09-20
Start date
2022-09-21
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

Healthy adults

Interventions

Study food 9 will be ingested over a period of 15 minutes. Placebo will be ingested over a period of 15 minutes.

Sponsors

Macromill, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 20 to under 40 at the time of informed consent. 2. Japanese male and female 3. BMI of less than 30 kg/m2 4. Those who does not smoke (who have not been smoking for the last year) 5. Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.

Exclusion criteria

Exclusion criteria: 1. Taking medication or Chinese medication (except for the dugs as needed) 2. Current of history of serious diseases such as heart, liver, kidney, gastrointestinal tract. 3. Those who has pollinosis or allergic rhinitis (seasonal/perennial) 4. Under diet of exercise therapy under the supervision of a doctor 5. Those who regularly uses any commercially available drug and quasi-drug, food for specified health use, food that affects autonomic nervous system, and sleep (however, the person will be eligible if he/she can stop using it during the study period after provision of the informed consent) 6. Subjects with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements. 7. Subjects who break out in a rash from putting electrodes on the chest. 8. Excessive consumption of alcohol (alcohol equivalent 60g or more /day) 9. Irregular diet, shift worker, night shift, irregular life rhythm 10. Those who has participated another clinical study within 1 month prior to provision of the informed consent or is currently participating in it, or will participate in it during the study period or within 4 weeks after the end of the study 11. Those who will be possibly under significant stress of any life event such as moving, changing his/her job, and separation from a close relative, within 3 months prior to provision of the informed consent, or will have such a life event during the study period 12. Those who has difficulty abstaining from alcohol staring from one day prior to the start of the study 13. Current of history of drug and/or food allergies 14. Those who is unable to drink alcohol constitutionally 15. Those who is in pregnancy or nursing 16. Judged by the investigator to be unsuitable for participating in this study

Design outcomes

Primary

MeasureTime frame
1. Questionnaires to assess the psychological impact

Secondary

MeasureTime frame
1. Physiological indicators that support psychology 2. Questionnaires

Countries

Japan

Contacts

Public ContactKohei Yoshida

Macromill, Inc. Life Science Division

koh_yoshida@macromill.com03-6716-0700

Outcome results

None listed

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