A study for evaluating effects of a single intake of the test food on EEG and autonomic nervous system.

Not Applicable

• Conditions: o

• Registration Number: JPRN-UMIN000048898
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-29
• Study Start: 2023-09-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

[1] Individuals using medical products. [2] Individuals who use a drug and Chinese traditional medicine. [3] Individuals who receive a diet remedy and an exercise therapy under medical supervision. [4] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [6] Individuals who are a patient or have a history of or endocrine disease. [7] Individuals who use implantable medical devices such as a pacemaker. [8] Individuals who used a drug to treat a disease in the past 1 month. [9] Individuals who use regularly over-the-counter medicines, quasi-drugs, food for specified health uses, functional foods, health foods and other products that affect the autonomic nervous system, metabolism and sleep. [10] Individuals who with a history of brain or heart surgery [11] Individuals who will develop seasonal allergy symptoms like hay fever or have allergic rhinitis during the test period. [12] Individuals who are or may be allergic to medical products or foods. [13] Individuals who have allergies to tape or other problems with EEG and heart rate monitor attachment. [14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [15] Individuals whose diet is extremely irregular. [16] Individuals whose daily life rhythm is irregular for reasons such as shift work or late nights. [17] Individuals who have experienced significant stress due to life events within 3 months prior to obtaining informed consent. [18] Individuals who are participating with other clinical trial. [19] Individuals who cannot stop drinking from the day before the test. [20] Individuals who are or are possibly pregnant, or are lactating. [21] Individuals who have severe menstrual complaints and require medication. [22] Individuals judged inappropriate for the study by the principal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified