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A study to evaluate the effects of functional food on body fat mass -Randomized, placebo-controlled, double-blind, parallel group comparison study-

A study to evaluate the effects of functional food on body fat mass -Randomized, placebo-controlled, double-blind, parallel group comparison study- - A study to evaluate the effects of functional food on body fat mass

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044936
Enrollment
80
Registered
2021-07-21
Start date
2021-07-10
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

Intake 5 tablets of the test food for 12 weeks Intake 5 tablets of the placebo food for 12 weeks

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females aged of 20-64 years at the date of informed consent 2) Subjects whose BMI 24 kg/m2 or more and less than 30 kg/m2 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 use pharmaceuticals affecting the study 2)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) 3)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 4)Subjects who declare some allergies to the components of the test food 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 7)Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators 8)Claustrophobic 9)Subjects who are currently pregnant or lactating, or who plan to become pregnant in the study period 10)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 11)Subjects judged as unsuitable for this study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Abdominal visceral fat area

Secondary

MeasureTime frame
Body weight, BMI, body fat percentage, abdominal total fat area, abdominal subcutaneous fat area, body composition (In Body), circumference, questionnaire survey

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

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