Safety Evaluation of Long-Term Intake of a Test Food

Not Applicable

• Conditions: o

• Registration Number: JPRN-UMIN000048665
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-15
• Study Completion: 2022-11-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

[1] Individuals using medical products. [2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3] Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [4] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5] Individuals who are a patient or have a history of or endocrine disease. [6] Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2. [7] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [8] Individuals who experienced unpleasant feeling during blood drawing. [9] Individuals with drug and food allergies. [10] Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent). [11] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [12] Individuals smoke an average of 21 or more cigarettes per day on a daily basis [13] Individuals who work late night or shift work, or have irregular lifestyle habits. Also, individuals who may change their lifestyle during the examination period. [14] Individuals who are pregnant, lactating, or may become pregnant. [15] Individuals who participated in other clinical studies in the past 3 months. [16] Individuals who are or whose family is engaged in healthy or functional foods. [17] Individuals judged inappropriate for the study by the principal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified