A Study on the Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Not Applicable

• Conditions: o (Subjects with normal liver function whose BMI are 23 or over and under 30)

• Registration Number: JPRN-UMIN000023475
• Lead Sponsor: KSO Corporation

Brief Summary

Statistically significant difference was confirmed in the Visceral fat area. Statistically significant difference was not confirmed in the Liver function enzyme.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-05
• Study Completion: 2016-12-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Subjects who use oral medications affecting obesity, hyperlipidemia, lipid metabolism, liver function, and so on. (2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism, liver function, and so on during test periods. (3) Subjects who can't stop drinking from 2 days before each measurement. (4) Subjects who contract, are under treatment for or have a history of liver disease. (5) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disorder). (6) Subjects who have declared allergic reaction to ingredients of test foods. (7) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (8) Subjects who have implanted metal in the abdominal area, as detected by computerized tomography. (9) Subjects who have implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator). (10) Subjects who have claustrophobia. (11) Subjects who are shiftworker and/or midnight-shift worker. (12) Subjects who have been diagnosed as familial hyperlipidemia. (13) Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating. (14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visceral fat area Liver function enzyme