Effect of a Test Food on Reducing Body Fat.

Not Applicable

• Conditions: o

• Registration Number: JPRN-UMIN000051158
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-25
• Study Completion: 2023-08-03
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

1) Individuals using medical products. 2) Individuals who used a drug to treat a disease in the past 1 month. 3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 4) Individuals who are a patient or have a history of or endocrine disease. 5) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 6) Individuals who have gained or lost 2 kg of body weight in the past 3 months. 7) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 8) Individuals who are sensitive to test product or other foods, and medical products. 9) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 10) Individuals with possible changes of lifestyle during the test period. 11) Individuals who currently or within the past 3 months have a habit of continuously taking health foods containing persimmon peel extract, or who plan to take them during the test period. 12) Individuals who have a habit to use drug claiming to reduce body fat in the past 3 months. 13) Individuals who are or are possibly pregnant or are lactating. 14) Individuals who participated in other clinical studies in the past 3 months. 15) Individuals who are or whose family is engaged in healthy or functional foods. 16) Individuals judged inappropriate for the study by the principal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
*Indexes for body fat 1) FatScan measurement of abdominal fat mass using CT scan images. (1) 2) Body composition. (Weight, body fat percentage, BMI) (2) (1): Week0, Week8 (2): Week0, Week4, Week8

Secondary Outcome Measures

Name	Time	Method
*Secondary indexes 1) Body composition. (Other Related Indicators) (1) 2) Waist girth, hip girth / waist-hip ratio (1) 3) Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ) (1) 4) Specific blood test (1) *Safety indexes 1) Blood pressure, pulsation(1) 2) Hematologic test (1) 3) Blood biochemical test (1) 4) Urine analysis (1) 5) Doctor's questions (1) 6) Side effects/ Adverse events (2) 7) Subject's diary (3) (1): Week0, Week4, Week8 (2): Week4, Week8 (3): From the first day of ingestion of a test material to the last day of the test.