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Validation of changes in autonomic nervous activity by a test-material consumption

Validation of changes in autonomic nervous activity by a test-material consumption - Validation of changes in autonomic nervous activity by a test-material consumption

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049341
Enrollment
24
Registered
2023-11-01
Start date
2022-11-01
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

Having a smell of the test liquid (100 mL) to the subjects for 2 min. Savoring the taste of the test liquid (30 mL) to the subjects for 1 min, and throwing it up. Having a smell of the placebo liquid

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Male/female subjects ranging in age from 20 to 34 at informed consent. (2) Subjects having less than 25.0 kg/m2 of BMI. (3) Subjects with no smoking (not less than one year). (4) Subjects who can give informed consent to take part in this trial, after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion criteria: (1) Subjects being under some kind of continuous medical treatment. (2) Subjects who have periodically used health-specific / functional / health foods including supplements, which might affect the autonomic nervous system, metabolism and sleep. (3) Subjects with incompatible eyeballs/eyelashes for pupillometry. (4) Subjects with any hindrances to a pupil measurement (e.g., dry eye). (5) Subjects having a subjective symptom of claustrophobia and nyctophobia. (6) Subjects with nasal congestion and wrong judgement of fragrance. (7) Subjects with excessive alcohol intake (not less than 60 g/day/week). (8) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one. (9) At the moment of informed consent, subjects who are under other clinical trials with some kind of medicine/food, or partook in those within four weeks before this trial. (10) 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 trial. (11) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (12) Subjects with a serious symptom of premenstrual syndrome at the moment of this trial. (13) Subjects who vaccinated within three days before this trial. (14) Pregnant, possibly pregnant, and lactating women. (15) Subjects having some kind of drug and/or food allergy. (16) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.

Design outcomes

Primary

MeasureTime frame
Pupil measurement

Secondary

MeasureTime frame
1. Psychological questionnaire 2. Skin temperature

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