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A confirmation study for effects of synbiotics on reducing body fat

A confirmation study for effects of synbiotics on reducing body fat: A randomized, double-blind, placebo-controlled parallel group study - A confirmation study for effects of synbiotics on reducing body fat

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049328
Enrollment
120
Registered
2024-01-13
Start date
2022-11-14
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

100g beverage containing bifidobacterium GCL2505 (1.10^10 CFU/mL) and inulin (2g) (once a day for 12 weeks), observation period (1 weeks) 100g placebo beverage containing neither bifidobacterium GCL25

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 of BMI between 23 and 30 3)Subjects who can stop drinking from 2 days before each measurement. 4)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 undertake medications that affect obesity, hyperlipidemia or lipid metabolism 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 health foods or supplements that affect obesity, hyperlipidemia or lipid metabolism 4)Subjects who can't limit the ingestion of foods which may affect intestinal microbiota 5)Subjects who are taking antibiotics and/or anti-microbe agents, or who had taken them within one month prior to the screening test 6)Subjects who regularly use intestinal drugs and laxatives (including strong laxatives) 7)Subjects with a digestive organ disease or surgical history that has an influence on digestive absorption 8)Subjects who declare some allergies to the components of the test product 9)Subjects who has a current or history of drug dependence and/or alcoholism 10)Subjects who have metal in the CT scan measurement site due to surgery, etc. 11) Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators 12) Claustrophobic 13)Subject who is pregnant or under lactation, or who is expected to be pregnant during the study 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 three months from the date of consent, or who plan to participate in others 15) Subjects who are judged unsuitable for this study by principal investigator

Design outcomes

Primary

MeasureTime frame
Visceral fat area(Week 12)

Secondary

MeasureTime frame
Visceral fat area(Week 8), Abdominal subcutaneous fat area(Week 8, 12), Abdominal total fat area(Week 8, 12), Body weight, Body-mass index, Body fat percentage (impedance method), waist circumference, hip circumference, W/H ratio, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, free fatty acid,fecal bifidobacteria

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