Examination of the effects of PD intake on autonomic nervous function in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.

Examination of the effects of PD intake on autonomic nervous function in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study. - The effects of PD intake on autonomic nervous function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029811

Enrollment

Registered

2018-12-16

Start date

2017-11-04

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

None

Interventions

Intake test drink (PD) for 8 days, and take wash out period for 6 days, and then, intake placebo drink for 8 days. Intake placebo drink for 8 days, and take wash out period for 6 days, and then, intak

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy males and females aged 20 years old or more.

Exclusion criteria

Exclusion criteria: 1) Subjects who have allergic reaction to drug or food. 2) Subjects who have a severe past medical history, acute infection, mental disorder, serious complications or need emergency medical care. 3) Subjects who are under treatment for insomnia, sleep disorder, dysautonomia or endocrine disease. 4) Subjects who expected big change in living environment from 1 month before this study to the end of the study. 5) Subjects who donated either 400 mL whole blood within 12 weeks or 200 mL whole blood within 4 weeks or blood components within 2 weeks prior to this study. 6) Subjects who get an intense exercise. 7) Subjects who are heavy smokers (more than 20 cigarettes per day). 8) Subjects who are alcohol addicts. 9) Subjects who take a drink with high content of caffeine excessively. 10) Subjects who regularly take a drink with high content of theanine. 11) Subjects who have an extremely irregular eating pattern and work the shift or work on midnight. 12) Subjects who are pregnant, lactating or expected to be pregnant during the study. 13) Subjects who regularly take medicine, food for specified health uses, foods with function claims and / or health food which would affect the result of the study. 14) Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks prior to the study. 15) Subjects who have difficulty in compliance with recording of various surveys. 16) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Design outcomes

Primary

Measure	Time frame
Autonomic nervous function during stress load	—

Secondary

Measure	Time frame
Autonomic nervous function and endocrine function during resting state	—

Countries

Japan

Contacts

Public ContactMasao Matsuoka

HUMA R&D CORP Clinical Development Division

matsuoka@huma-c.co.jp03-3431-1260

Outcome results

None listed

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