Safety of Consecutive Intake of a Test Food.

Not Applicable

• Conditions: /A(healthy adults)

• Registration Number: JPRN-UMIN000036254
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Study Completion: 2019-04-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 12

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 or over 30.0kg/m2. [7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals who experienced unpleasant feeling during blood drawing. [10]Individuals who are sensitive to a test product or other foods, and medical products. [11]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). [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [13]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [14]Individuals who are or are possibly, or are lactating. [15]Individuals who participated in other clinical studies in the past 3 months. [16]Individuals who are or whose family is engaged in functional foods or cosmetics. [17]Individuals judged inappropriate for the study by the principal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[1]Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (during analyzing test results).

Secondary Outcome Measures

Name	Time	Method
*Secondary outcomes [1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (Week 0, Week 4). [2]Blood pressure, pulsation (Week 0, Week 4). [3]Weight, body fat percentage, BMI (Week 0, Week 4). [4]Hematologic test (Week 0, Week 4). [5]Blood biochemical test (Week 0, Week 4). [6]Urine analysis (Week 0, Week 4). [7]Doctor's questions (Week 0, Week 4). *Other index [1]Subject's diary (each day during the test period).