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| Name | Class |
|---|---|
| Marukome Co., Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Koji-extracted beverage | Placebo Comparator | 100ml/day for 12 weeks |
|
| Koji-extracted beverage fermented with LP28 | Experimental | 100ml/day for 12 weeks. 1x10^11 cells (LP28)/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement |
| ||
| Koji-extracted beverage fermented with Pediococcus pentosaceus LP28 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fumiko Higashikawa, PhD | Hiroshima University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiroshima University | Hiroshima | Hiroshima | 734-8551 | Japan |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Dietary Supplement |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |