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Verification of impacts on brain activity, by test-food intake in a single dose

Verification of impacts on brain activity, by test-food intake in a single dose - Verification of impacts on brain activity, by test-food intake in a single dose

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049216
Enrollment
24
Registered
2023-10-18
Start date
2022-10-18
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 male/female adults

Interventions

Ingestion of the test liquid (200 mL) to the volunteers within 3 min. Ingestion of the placebo liquid (200 mL) to the volunteers within 3 min.

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Male/female volunteers ranging in age from 20 to 34 at informed consent. (2) Volunteers having less than 25.0 kg/m2 of BMI. (3) Volunteers with no smoking (not less than a year). (4) Volunteers 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) Volunteers being under some kind of continuous medical treatment, including the test period. (2) Volunteers who have periodically used health-specific / functional / health foods including supplements, which might affect the autonomic nervous system, metabolism and sleep. (3) Volunteers with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements. (4) Volunteers with excessive alcohol intake (not less than 60 g/day/week). (5) Volunteers with extremely irregular eating habits, and volunteers having an irregular life rhythm with irregular shift work or midnight one. (6) At the moment of informed consent, volunteers who are under other clinical tests with some kind of medicine/food, or partook in those within four weeks before the current study, or are planning to take part in those after the consent. (7) Volunteers 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 test period. (8) Volunteers with any difficulty in giving up drinking since the day before the scheduled date of this study. (9) Volunteers with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (10) Volunteers getting excessive exercise every day. (11) Volunteers with a serious symptom of premenstrual syndrome. (12) Volunteers who have been determined as poor blood circulation, according to the doctor's oral questions at the moment of informed consent. (13) Volunteers planning to vaccinate within three days before this study. (14) Pregnant, possibly pregnant, and lactating women. (15) Volunteers having some kind of drug and/or food allergy. (16) Volunteers who break out in a rash from putting electrodes on the head and chest. (17) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.

Design outcomes

Primary

MeasureTime frame
Brain activity

Secondary

MeasureTime frame
1. Heartbeat 2. Psychological questionnaire 3. Skin temperature 4. Subjective vitality scale (Japanese ver.)

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