Study on psychological changes at ingestion of the test product.

UMIN ID: UMIN000050900

Registered date:21/04/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2023/04/24
• Target sample size: 54
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake test beverage on the day. Washout. Intake placebo beverage on the day.
Intake placebo beverage on the day. Washout. Intake test beverage on the day.

Outcome(s)

• Primary Outcome: Psychological evaluation questionnaire
• Secondary Outcome: (Secondary outcomes) Heart rate sensor measurement data. (Safety evaluation) Vital signs, physical measurements (body weight, BMI), adverse events.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 35years-old
• Gender: Male and Female
• Exclude criteria: 1.Subject receiving medication or outpatient treatment for a serious disease.(Use on a PRN(as needed) basis will be permitted.) 2.Subject receiving exercise or diet therapy under the supervision of a physician. 3.Subject who has currently taking any products (e.g., foods for specified health use, foods with functional claims, dietary supplements or health foods, drugs, quasi-drugs) that can affect the autonomic nervous system, metabolism, or sleep, and are unable to discontinue taking them during the study period. 4.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past. 5.Subject with a history or current illnesses of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc. 6.Subject who has problems with heart rate measurement (thick chest hair, using a pacemaker, rash on the skin (chest), etc.) 7.Heavy drinker. 8.Subject who has difficulty quitting drinking from the day before the test date. 9.Subject who has extremely irregular eating habits, those who work shifts, those who work late at night, etc. 10.Subject who is participating in other clinical trials at the time of obtaining consent, and who plans to participate in other clinical trials within 4 weeks from the end of the study to the start of the main study of the study, or after consenting to participate in the study. 11.Subject who has moved residences, changed jobs, separated from close relatives, or had equivalent events within the last 3 months and thus are likely to be under a great deal of stress, or who may have such an event during the study period. 12.Subject who exercises violently on a daily basis. 13.Subject with severe PMS (premenstrual syndrome) symptoms. 14.Subject who is planning to get pregnant during the test period after the day of informed consent or is currently pregnant and lactating.

Related Information

• Primary Sponsor: HUMA R&D CORP
• Source(s) of Monetary Support: Asahi Quality & Innovations, Ltd