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| Name | Class |
|---|---|
| Inner Mongolia Yili Industrial Group Co., Ltd | INDUSTRY |
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The aim of the present study was to investigate the effect of intervention with Lactobacillus paracasei K56 on body fat, metabolic risk markers,inflammatory markers and gut microbiota composition in obesity.
Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity.
In this randomised,double blind ,placebo controlled study, the participants were randomly assigned to probiotic K56 group or placebo group to evaluate the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing probiotic or placebo capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic K56 | Experimental | Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days |
|
| placebo | Placebo Comparator | placebo capsule(maltodextrin, 1capsule/day, 60days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus paracasei K56 | Dietary Supplement | probiotic K56 capsule, 1capsule/day (10^9cfu) ,for 60days |
|
| Measure | Description | Time Frame |
|---|---|---|
| visceral fat area (cm^2) | VFA (cm^2) will be assessed at baseline and after 60days of intervention | 60days |
| percent body fat (%) | PBF (%) will be assessed at baseline and after 60days of intervention | 60days |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | Body weight (kg) will be assessed at baseline and after 60days of intervention | 60days |
| Body Mass Index BMI | Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention |
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Inclusion Criteria:
(Note: If PBF was eligible, it was recommended that 26 ≤ BMI ≤ 40)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Feng, Ph.D | Contact | +86 18121221972 | yingfenghd@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Feng, Ph.D | Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hua Dong Hospital Affiliated to Fu Dan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| placebo | Dietary Supplement | placebo capsule(maltodextrin) , 1capsule/day ,for 60days |
|
| 60 days |
| waist circumference (cm) | will be assessed at baseline and after 60days of intervention | Baseline, 60 days |
| hip circumference(cm) | will be assessed at baseline and after 60days of intervention | 60 days |
| waist to hip ratio (WHR) | waist to hip ratio (WHR) will be assessed at baseline and after 60days of intervention | 60 days |
| Serum Lipid Profile | Serum total cholesterol(mmol/L),Serum triglycerides(mmol/L),Low-density lipoprotein(mmol/L),High density lipoprotein(mmol/L) will be measured at baseline and after 60days of intervention | 60 days |
| fasting blood glucose | fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention | 60 days |
| Glycated hemoglobin | Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention | 60 days |
| Glycosylated albumin | Glycosylated albumin(%) will be measured at baseline and after 60days of intervention | 60days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |