Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study

Conditions
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Obesity, Adiposity

Intervention / Treatment
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* Dietary Supplement: probiotic drink with Lactobacillus paracasei K56
* Dietary Supplement: maltodextrin
* Dietary Supplement: Probiotic powder E3
* Dietary Supplement: Probiotic powder E5
* Dietary Supplement: probiotic capsule E7
* Dietary Supplement: probiotic capsule E9
* Dietary Supplement: probiotic capsule E10
* Dietary Supplement: probiotic capsule E11


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI>=30kg/m2,or percent of body fat(PBF) >=25% for male, >=30 for female. Age: 18 - 60 years old adults Exclusion Criteria: patients with severe chronic diseases (coronary heart disease, diabetes, hypertension, immune deficiency, mental disorders, tumors, liver and kidney dysfunction, etc.) and complications;irritable bowel syndrome History of intervention with fat-reducing drugs or health products in the past 2 months take weight control measures (diet, exercise, etc.) within the past month Those who cannot guarantee to maintain their current lifestyle during the trial period Those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: K56 very high dose -E1<br>Probiotic drink (lactobacillus paracasei K56 10^11CFU) 350ml/d , for 60days | Dietary Supplement: probiotic drink with Lactobacillus paracasei K56<br>* Probiotic drink (K56 10^11CFU) 350ml/d for 60days<br>|
| Placebo Comparator: control -E2<br>maltodextrin , for 60days | Dietary Supplement: maltodextrin<br>* maltodextrin ,for 60days<br>|
| Active Comparator: K56 high dose-E3<br>Probiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10^10cfu) , for 60days | Dietary Supplement: Probiotic powder E3<br>* Probiotic powder 3.0g/d (K56 10^10cfu) 60days;<br>|
| Active Comparator: K56 middle dose-E5<br>Probiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10^9cfu) , for 60days | Dietary Supplement: Probiotic powder E5<br>* probiotic powder 8g/day for 60days<br>|
| Active Comparator: K56 low dose -E7<br>probiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10^7cfu) , for 60days | Dietary Supplement: probiotic capsule E7<br>* probiotic k56 capsule, 2capsules/d (10^7cfu) for 60days<br>|
| Active Comparator: K56 middle dose-E9<br>probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^9cfu) ,for 60days | Dietary Supplement: probiotic capsule E9<br>* probiotic k56 capsule, 2capsules/d (10^9cfu) for 60days<br>|
| Active Comparator: K56 high dose-E1K<br>probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^10cfu), for 60days | Dietary Supplement: probiotic capsule E10<br>* probiotic k56 capsule, 2capsules/d (10^10cfu) for 60days<br>|
| Active Comparator: K56 very high dose-E11<br>probiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10^11cfu) ,for 60days | Dietary Supplement: probiotic capsule E11<br>* probiotic k56 capsule, 4capsules/d (10^11cfu) for 60days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visceral fat area, obesity, lactobacillus paracasei, body fat