A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036031

Enrollment

120

Registered

2019-03-01

Start date

2019-03-02

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

None listed

Interventions

Food containing low-dose plant extract Food containing medium-dose plant extract Food containing high-dose plant extract Food not containing plant extract

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females aged 20 to 64 years-old. (2)Subjects whose BMI are 23 or over and under 30. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Visceral fat area	—

Secondary

Measure	Time frame
Subcutaneous fat area, Total fat area, Body weight(BMI), Waist circumference, Hip circumference, Waist circumference/ Hip circumference	—

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results