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An exploratory study for examining the effects of PE on relaxation and stress in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study.

An exploratory study for examining the effects of PE on relaxation and stress in healthy adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study. - The effects of PE on relaxation and stress

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024808
Enrollment
24
Registered
2017-12-18
Start date
2016-11-12
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 of test food (PE) for a week, then intake of placebo for a week after wash-out period. Intake of placebo for a week, then intake of test food (PE) for a week after wash-out period.

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

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 and food 2)Subjects who have a severe past medical history, acute infection, or mental disorder 3)Subjects who are heavy smokers (more than 20 cigarettes per day) 4) Subjects who are alcohol addicts 5)Subjects who have an extremely irregular eating pattern and work the shift or the graveyard shift 6)Subjects who are pregnant, lactating or expected to be pregnant during the study 7)Subjects who regularly take medicine, food for specified health uses, and/or health food which would affect the result of the study 8)Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks prior to the study 9)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Questionnaire of relaxation/stress

Countries

Japan

Contacts

Public ContactToshiyasu Tamura

TES Holdings Co., Ltd. Division of Clinical Trial, Department of Development for Clinical Trials

info@tes-h.co.jp03-6801-8480

Outcome results

None listed

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