Effect of a Test Food on Body Compositio

Not Applicable

• Conditions: o

• Registration Number: JPRN-UMIN000044540
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Study Completion: 2021-09-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

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 who recorded weight gain and loss (+-2 kg) 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 who are picky eater or have irregular eating habits. [11]Individuals who will change life style and exercise habits during the test period (ex. long term travel and gym visits). [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, 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 functional foods or cosmetics. [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
[1]Body fat percentage/Body fat mass(1) (1):Week 0, Week 8, Week 12.

Secondary Outcome Measures

Name	Time	Method
*Secondary outcomes [1]Indexes based on body composition classification. [2]Waist girth, hip girth / waist-hip ratio(1) [3]Weight measurement at the participant's own home. *Safety [1]Blood pressure, pulsation(1) [2]Hematologic test(3) [3]Blood biochemical test(3) [4]Urine analysis(3) [5]Doctor's questions(1) [6]Subject's diary(4) *Other index [1]brief-type self-administered diet history questionnaire [2]Dietary survey (Changes of dietary habits during the 3 days prior to each observation day and throughout each 4-week period.) (1)Week 0, Week 8, Week 12. (2)Once a week from the start date of ingestion until the end date of the study. (3)Week 0, Week 12. (4)From the first day of ingestion of a test material to the last day of the test. (5)Week 0.