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A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass - Randomized placebo-controlled double-blind parallel group comparison study -

A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass - Randomized placebo-controlled double-blind parallel group comparison study - - A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039251
Enrollment
110
Registered
2021-05-23
Start date
2020-02-26
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

Interventions

Sponsors

KSO CORPORATION
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Japanese males and females aged of 20-64 years at the date of the informed consent 2) Subjects whose BMI values are 27.0 or more and less than 32.0 3) Subjects who have received a sufficient explanation of the purpose and content of the study, have the consent ability and good understandings, and have agreed voluntarily in writing to participate in the study

Exclusion criteria

Exclusion criteria: 1) Subjects who regularly use pharmaceuticals 2) Subjects who cannot stop taking supplements and health foods (including foods for specified health use and foods with functional claims) that may affect something for the test in the study period 3) Subjects who have a history of severe kidney disease, heart disease, respiratory disease, endocrine disease, diabetes, etc., and undergoing treatment for them (excluding transient treatment such as colds) 4) Subjects who declare some allergies to the components of the test product 5) Subjects who have a history of drug/alcohol dependence or a current medical history 6) Subjects who have metal by surgery and others in measurement areas for CT scan and dual scan 7) Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators 8) Claustrophobic 9) Subjects who plan to travel overseas or have a long business trip during this study period 10) Subjects who cannot take the test food as instructed 11) Subjects who cannot maintain daily living habits, such as shift workers and late-night workers 12) Smokers exceeding 20 cigarettes per day, subjects who regularly take more than 40 g per day of alcohol 13) Subjects who are currently pregnant or lactating, or who plan to become pregnant in the study period 14) Subjects who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals, who have participated in other clinical studies within the past month from the date of consent, or who plan to participate in others 15) Subjects judged as unsuitable for this study by the principal investigator

Design outcomes

Primary

MeasureTime frame
abdominal total fat area, BMI

Secondary

MeasureTime frame
body weight, body fat percentage, abdominal visceral fat area, abdominal subcutaneous fat area, waist circumference, hip circumference, W/H ratio, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, fasting blood glucose, HbA1c

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO CORPORATION Department of Facility Management

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

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