Verification of effects on autonomic nervous system, by inhalation of test food-inducing aroma

UMIN ID: UMIN000051292

Registered date:14/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy male/female volunteers
• Date of first enrollment: 2023/06/14
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Having a smell of the test food-inducing aromas to the volunteers for 2 min.

Outcome(s)

• Primary Outcome: Pupil measurement
• Secondary Outcome: 1. Subjective questionnaire 2. Skin temperature 3. Near-Infrared spectroscopy

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 50years-old
• Gender: Male and Female
• Exclude criteria: (1) Volunteers being poor at having a smell of any kind of tea. (2) Volunteers falling into the habit of smoking (not less than half a year). (3) Volunteers who have periodically used health-specific / functional (e.g., gamma-aminobutyric acid, L-theanine)/ health foods including supplements, which might affect the trial results. (4) Volunteers with incompatible eyeballs/eyelashes for pupillometry. (5) Volunteers with any hindrances to a pupil measurement (e.g., dry eye). (6) Volunteers having a subjective symptom of claustrophobia and nyctophobia. (7) Volunteers being under some kind of continuous medical treatment. (8) Volunteers with the condition of being over-sensitiveness to cold, even during the summer season. (9) Volunteers with nasal congestion and/or wrong judgement of fragrance. (10) Volunteers having previous/present medical history of serious diseases in heart, liver, kidney, and/or digestive organs. (11) Volunteers with an external injury on their forehead or finger. (12) Volunteers with some kind of skin symptom, disease or disorder (e.g., atopic dermatitis). (13) Pregnant, possibly pregnant, or lactating women. (14) Volunteers who are now under another clinical test with some kind of medicine/food, or partook in that within a month before this trial. (15) Others who have been determined as ineligible for participation, according to the investigator's opinions.

Related Information

• Primary Sponsor: CPCC Company Limited
• Secondary Sponsor: Graduate School of Comprehensive Human Sciences, Tsukuba University
• Source(s) of Monetary Support: ITOEN, LTD.