Obesity
Conditions
Keywords
obesity, lactobacillus paracasei, body fat, visceral fat area, gut microbiota
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus paracasei K56
probiotic K56 capsule, 1capsule/day (10\^9cfu) ,for 60days
DIETARY_SUPPLEMENTplacebo
placebo capsule(maltodextrin) , 1capsule/day ,for 60days
Sponsors
Inner Mongolia Yili Industrial Group Co., Ltd
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visceral fat area (cm^2) | 60days | VFA (cm\^2) will be assessed at baseline and after 60days of intervention |
| percent body fat (%) | 60days | PBF (%) will be assessed at baseline and after 60days of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| waist circumference (cm) | Baseline, 60 days | will be assessed at baseline and after 60days of intervention |
| hip circumference(cm) | 60 days | will be assessed at baseline and after 60days of intervention |
| waist to hip ratio (WHR) | 60 days | waist to hip ratio (WHR) will be assessed at baseline and after 60days of intervention |
| body weight | 60days | Body weight (kg) will be assessed at baseline and after 60days of intervention |
| fasting blood glucose | 60 days | fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention |
| Glycated hemoglobin | 60 days | Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention |
| Glycosylated albumin | 60days | Glycosylated albumin(%) will be measured at baseline and after 60days of intervention |
| Serum Lipid Profile | 60 days | 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 |
| Body Mass Index BMI | 60 days | Body Mass Index (kg/m\^2) will be assessed at baseline and after 60days of intervention |
Countries
China
Contacts
Primary ContactYing Feng, Ph.D
Outcome results
None listed