Adiposity, Obesity
Conditions
Keywords
obesity, lactobacillus paracasei, body fat, visceral fat area
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTprobiotic drink with Lactobacillus paracasei K56
Probiotic drink (K56 10\^11CFU) 350ml/d for 60days
DIETARY_SUPPLEMENTmaltodextrin
maltodextrin ,for 60days
DIETARY_SUPPLEMENTProbiotic powder E3
Probiotic powder 3.0g/d (K56 10\^10cfu) 60days;
DIETARY_SUPPLEMENTProbiotic powder E5
probiotic powder 8g/day for 60days
DIETARY_SUPPLEMENTprobiotic capsule E7
probiotic k56 capsule, 2capsules/d (10\^7cfu) for 60days
DIETARY_SUPPLEMENTprobiotic capsule E9
probiotic k56 capsule, 2capsules/d (10\^9cfu) for 60days
DIETARY_SUPPLEMENTprobiotic capsule E10
probiotic k56 capsule, 2capsules/d (10\^10cfu) for 60days
DIETARY_SUPPLEMENTprobiotic capsule E11
probiotic k56 capsule, 4capsules/d (10\^11cfu) for 60days
Sponsors
Inner Mongolia Yili Industrial Group Co., Ltd
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percent body fat | 60days | percent body fat (%) will be assessed at baseline and after 60days of intervention |
| visceral fat area | 60days | visceral fat area (cm\^2) will be assessed at baseline and after 60days of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin | 60 days | Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention |
| Glycosylated albumin | 60 days | Glycosylated albumin(%) will be measured at baseline and after 60days of intervention |
| skeletal muscle mass | 60 days | skeletal muscle mass (kg) will be assessed 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 |
| body weight | 60 days | Body weight (kg) 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 |
| fasting blood glucose | 60 days | fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention |
Countries
China
Outcome results
None listed