Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

Study Overview
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Brief Summary
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This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.

Official Title
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A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Koji-extracted beverage fermented with Pediococcus pentosaceus LP28


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 25-30 kg/m2 Exclusion Criteria: Taking drugs or functional food that may affect body weight or body fat Pregnant or nursing a child Participation in any clinical trial within 90 days of the commencement of the trial Renal or hepatic dysfunction Heart disease History of severe disease and/or major surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Koji-extracted beverage<br>100ml/day for 12 weeks | Dietary Supplement: Placebo<br> <br> |
| Experimental: Koji-extracted beverage fermented with LP28<br>100ml/day for 12 weeks. 1x10^11 cells (LP28)/day | Dietary Supplement: Koji-extracted beverage fermented with Pediococcus pentosaceus LP28<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI from baseline |  | Every 4 weeks (Overall 12 weeks) | 
| Change in body fat mass (percentage) from baseline |  | Every 4 weeks (Overall 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal circumference from baseline |  | Every 4 weeks (Overall 12 weeks) | 
| Change in visceral fat area by CT scan from baseline |  | Weeks 0 and 12 | 
| Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline |  | Weeks 0 and 12 | 
| Change in fasting plasma glucose from baseline |  | Every 4 weeks (Overall 12 weeks) | 
| Change in serum triglyceride from baseline |  | Every 4 weeks (Overall 12 weeks) | 
| Change in serum total cholesterol from baseline |  | Every 4 weeks (Overall 12 weeks) | 
| Change in serum LDL cholesterol from baseline |  | Every 4 weeks (Overall 12 weeks) | 
| Change in serum HDL cholesterol from baseline |  | Every 4 weeks (Overall 12 weeks) | 
| Change in fasting insulin from baseline |  | Weeks 0 and 12 | 
| Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline | HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405 | Weeks 0 and 12 |