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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-

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- - The Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023475
Enrollment
130
Registered
2016-08-05
Start date
2016-08-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No (Subjects with normal liver function whose BMI are 23 or over and under 30)

Interventions

Food containing pueraria flower extract Food not containing pueraria flower extract

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females aged 20 to 64 years old. (2) Subjects whose AST and ALT are up to 50 U/L, and gamma-GTP are up to 100 U/L(males) or 60 U/L(females). (3) Subjects whose BMI are 23 or over and under 30. (4) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Visceral fat area Liver function enzyme

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026