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A confirmation study for effects of synbiotics on reducing body fat

Not Applicable
Conditions
one
Registration Number
JPRN-UMIN000049328
Lead Sponsor
KSO Corporation
Brief Summary

Participants consumed a test beverage containing 1 * 10^10 colony-forming units of Bifidobacterium animalis subsp. lactis GCL2505 per 100 g and 2.0 g of inulin per 100 g for 12 weeks. There were significant reductions in visceral fat area and total fat area. The intervention significantly increased the total number of bifidobacteria and affected the levels of several lipid markers.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Visceral fat area(Week 12)
Secondary Outcome Measures
NameTimeMethod
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
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