Validation study of effects on brain function by test-food intake in a single dose

UMIN ID: UMIN000051211

Registered date:06/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy male/female adults
• Date of first enrollment: 2023/06/06
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of the test liquid (200 mL) to the subjects within 5 min.
Ingestion of the placebo (200 mL water) to the subjects within 5 min.

Outcome(s)

• Primary Outcome: Cognitrax (symbol-digit coding, stroop, and shifting attention)
• Secondary Outcome: 1. The Profile of Mood States Second Edition (Japanese short ver.) 2. Psychological questionnaire 3. Heartbeat

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 35years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects being under some kind of continuous medical treatment, including the study period. (2) Subjects who have periodically used health-specific / functional (e.g., gamma-aminobutyric acid, L. gasseri CP2305)/ health foods including supplements, which might affect the autonomic nervous system, stress, fatigue and brain function. (3) Subjects with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements. (4) Subjects with excessive alcohol intake. (5) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one. (6) Subjects who are under other clinical tests with some kind of medicine/food, or participated in those within four weeks before this study, or are planning to join those after the consent. (7) Subjects who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this study and during the study period. (8) Subjects with any difficulty in giving up drinking since the day before the scheduled date of this study. (9) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (10) Subjects getting excessive exercise every day. (11) Subjects with a serious symptom of premenstrual syndrome. (12) Pregnant, possibly pregnant, and lactating women. (13) Subjects having some kind of drug and/or food allergy. (14) Subjects who break out in a rash from putting electrodes on the head and chest. (15) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: Asahi Quality & Innovations, Ltd.