Clinical Study of Psychological Impact of Food Ingredients

UMIN ID: UMIN000051027

Registered date:24/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2023/04/26
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Study food AIX-7 will be ingested over a period of 15 minutes.
Placebo will be ingested over a period of 15 minutes.

Outcome(s)

• Primary Outcome: 1. Questionnaires to assess the psychological impact
• Secondary Outcome: 1. Physiological indicators that support psychology 2. Questionnaires

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Macromill, Inc.
• Source(s) of Monetary Support: Asahi Quality & Innovations, Ltd.