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A study on the effects of the test product's flavor on relaxation - A Randomized, Open-Label, Crossover Trial

A study on the effects of the test product's flavor on relaxation - A Randomized, Open-Label, Crossover Trial - A study on the effects of the test product's flavor on relaxation - A Randomized, Open-Label, Crossover Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058213
Enrollment
20
Registered
2025-06-18
Start date
2025-06-18
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 adults

Interventions

Participants smell the aroma of the test product and then ingest the 150mL volume. Participants smell the aroma of the control product and then ingest the 150mL volume.

Sponsors

KOBAYASHI Pharmaceutical Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy men and women aged 20 to 65. 2) Individuals of Japanese nationality. 3) Employees of Kobayashi Pharmaceutical Co., Ltd. 4) Individuals who have understood the purpose and procedures of this study and have voluntarily provided written informed consent to participate.

Exclusion criteria

Exclusion criteria: 1) Individuals with an aversion to the flavor of test products. 2) Current smokers or those who have quit smoking for less than 6 months. 3) Individuals with a habit of excessive alcohol consumption (defined as a daily pure alcohol intake of 40g or more for men, and 20g or more for women). 4) Individuals currently using any medications, quasi-drugs, health foods, supplements, or Foods with Function Claims (e.g., GABA, L-theanine) purported to have stress-reducing or relaxing effects. 5) Individuals who plan significant changes to their lifestyle (e.g., diet, sleep, exercise habits), including long-term travel, during the study period. 6) Individuals taking any medication on a continuous basis for therapeutic purposes. 7) Individuals with nasal congestion (e.g., due to allergic rhinitis) or those unable to perceive or judge aromas. 8) Individuals with a history of or current serious disease of the heart, liver, kidneys, or digestive system. 9) Individuals with injuries on their forehead or left index finger. 10) Women who are pregnant, lactating, or planning to become pregnant. 11) Individuals currently participating in another clinical study or who have completed participation within one month prior to the start of this study. 12) Individuals with self-reported physical discomfort due to low atmospheric pressure.

Design outcomes

Primary

MeasureTime frame
Brain waves

Secondary

MeasureTime frame
Changes in Heart Rate Variability (HRV) parameters Visual analogue scale Likert scale

Countries

Japan

Contacts

Public ContactMasaya Tsujikami

KOBAYASHI Pharmaceutical Co., Ltd. Life Science Research Department R&D Headquarters

m.tsujikami@kobayashi.co.jp072-640-0121

Outcome results

None listed

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