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Evaluation test of changes in autonomic nervous activity by test-food intake in a single dose

Evaluation test of changes in autonomic nervous activity by test-food intake in a single dose - Evaluation test of changes in autonomic nervous activity by test-food intake in a single dose

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040849
Enrollment
16
Registered
2021-06-22
Start date
2020-06-23
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 adults

Interventions

Consumption of the test liquid (200 mL) or the test food (4 drops with 200 mL water) to the subjects within 2 min. Consumption of the placebo (200 mL water) to the subjects within 2 min.

Sponsors

Chiyoda Paramedical Care Clinic
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1) Healthy male subjects ranging in age from 20 to 49. (2) Subjects with less than 25.0 kg/m2 BMI. (3) No smoking subjects (over recent one year). (4) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion criteria: (1) Subjects with some kind of medical treatment continuously, combining the test period. (2) Subjects who have regularly used health-specific / functional / health foods, which might affect the autonomic nervous system, metabolism and sleep. (3) Subjects with incompatible eyeballs/eyelashes for pupillometry. (4) Subjects who have any difficulty in equipping a pulse-rate meter. (5) Subjects with excessive alcohol intake. (6) Subjects with extremely irregular life rhythms, and subjects with midnight work or irregular shift work. (7) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated those tests within four weeks after the current trial. (8) Subjects who are under large stress condition with some kind of life event, such as house-moving, bereavement, etc., within three months before the agreement for this trial. (9) Subjects with difficulty in giving up drinking since the day before the scheduled date of this trial. (10) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (11) Subjects with previous medical history of drug and/or food allergy. (12) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.

Design outcomes

Primary

MeasureTime frame
Electronic pupillometer-measurement data

Secondary

MeasureTime frame
1. Electronic pupillometer-measurement data 2. Heart rate sensor-measurement data 3. Physiological measurement data 4. Questionnaire

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Planning & Sales Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026