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| Name | Class |
|---|---|
| Inner Mongolia Yili Industrial Group Co., Ltd | INDUSTRY |
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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 before-after pilot study, the participants were randomly assigned to 8 groups to compare the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing different product prototypes , and screen the best probiotic K56 prototype with the effect of fat reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K56 very high dose -E1 | Active Comparator | Probiotic drink (lactobacillus paracasei K56 10^11CFU) 350ml/d , for 60days |
|
| control -E2 | Placebo Comparator | maltodextrin , for 60days |
|
| K56 high dose-E3 | Active Comparator | Probiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10^10cfu) , for 60days |
|
| K56 middle dose-E5 | Active Comparator | Probiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10^9cfu) , for 60days |
|
| K56 low dose -E7 | Active Comparator | probiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10^7cfu) , for 60days |
|
| K56 middle dose-E9 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic drink with Lactobacillus paracasei K56 | Dietary Supplement | Probiotic drink (K56 10^11CFU) 350ml/d for 60days |
|
| Measure | Description | Time Frame |
|---|---|---|
| percent body fat | percent body fat (%) will be assessed at baseline and after 60days of intervention | 60days |
| visceral fat area | visceral fat area (cm^2) will be assessed at baseline and after 60days of intervention | 60days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36944956 | Derived | Kadeer G, Fu W, He Y, Feng Y, Liu WH, Hung WL, Feng H, Zhao W. Effect of different doses of Lacticaseibacillus paracasei K56 on body fat and metabolic parameters in adult individuals with obesity: a pilot study. Nutr Metab (Lond). 2023 Mar 21;20(1):16. doi: 10.1186/s12986-023-00739-y. |
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probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^9cfu) ,for 60days |
|
| K56 high dose-E1K | Active Comparator | probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^10cfu), for 60days |
|
| K56 very high dose-E11 | Active Comparator | probiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10^11cfu) ,for 60days |
|
| maltodextrin | Dietary Supplement | maltodextrin ,for 60days |
|
| Probiotic powder E3 | Dietary Supplement | Probiotic powder 3.0g/d (K56 10^10cfu) 60days; |
|
| Probiotic powder E5 | Dietary Supplement | probiotic powder 8g/day for 60days |
|
| probiotic capsule E7 | Dietary Supplement | probiotic k56 capsule, 2capsules/d (10^7cfu) for 60days |
|
| probiotic capsule E9 | Dietary Supplement | probiotic k56 capsule, 2capsules/d (10^9cfu) for 60days |
|
| probiotic capsule E10 | Dietary Supplement | probiotic k56 capsule, 2capsules/d (10^10cfu) for 60days |
|
| probiotic capsule E11 | Dietary Supplement | probiotic k56 capsule, 4capsules/d (10^11cfu) for 60days |
|
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 | 60 days |
| skeletal muscle mass | skeletal muscle mass (kg) 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 |
| Body Mass Index BMI | Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention | 60 days |
| body weight | Body weight (kg) will be assessed at baseline and after 60days of intervention | 60 days |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D019936 | Probiotics |
| C005629 | E 10 |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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