The Effect of Intervention With Probiotic K56 on Body Fat Reduction in Obese Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Evaluation of the Effects of a Probiotic Strain Lactobacillus Paracasei K56 on Body Fat Reduction in Middle-aged Obese Subjects：A Randomized, Double-Blind, Placebo-Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Lactobacillus paracasei K56
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity : BMI>=30kg/m2,or percent body fat(PBF) >=25% for male, >=30% for female. （Note: If PBF was eligible, it was recommended that 26 ≤ BMI ≤ 40） Age: 40 - 65 years old adults Who has the conditions to preserve the test samples at low temperature throughout the whole process Exclusion Criteria: Patients with severe chronic diseases（heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental illness and organ surgery history, etc.) and complications; Patients with severe allergy and immunodeficiency; Patients with a clear history of gastrointestinal diseases (ulcer, irritable bowel syndrome, etc.); 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 Participation in other clinical trials within the past 3 months who have used antibiotics in the past 2weeks ; 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: 40 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic K56<br>Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days | Dietary Supplement: Lactobacillus paracasei K56<br>* probiotic K56 capsule, 1capsule/day (10^9cfu) ,for 60days<br>|
| Placebo Comparator: placebo<br>placebo capsule(maltodextrin, 1capsule/day, 60days | Dietary Supplement: placebo<br>* placebo capsule(maltodextrin) , 1capsule/day ,for 60days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

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