Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fudan University
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- visceral fat area
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
K56 very high dose -E1
Probiotic drink (lactobacillus paracasei K56 10^11CFU) 350ml/d , for 60days
Intervention: probiotic drink with Lactobacillus paracasei K56 (Dietary Supplement)
K56 high dose-E3
Probiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10^10cfu) , for 60days
Intervention: Probiotic powder E3 (Dietary Supplement)
K56 middle dose-E5
Probiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10^9cfu) , for 60days
Intervention: Probiotic powder E5 (Dietary Supplement)
K56 low dose -E7
probiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10^7cfu) , for 60days
Intervention: probiotic capsule E7 (Dietary Supplement)
K56 middle dose-E9
probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^9cfu) ,for 60days
Intervention: probiotic capsule E9 (Dietary Supplement)
K56 high dose-E1K
probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^10cfu), for 60days
Intervention: probiotic capsule E10 (Dietary Supplement)
K56 very high dose-E11
probiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10^11cfu) ,for 60days
Intervention: probiotic capsule E11 (Dietary Supplement)
control -E2
maltodextrin , for 60days
Intervention: maltodextrin (Dietary Supplement)
Outcomes
Primary Outcomes
visceral fat area
Time Frame: 60days
visceral fat area (cm\^2) will be assessed at baseline and after 60days of intervention
percent body fat
Time Frame: 60days
percent body fat (%) will be assessed at baseline and after 60days of intervention
Secondary Outcomes
- Serum Lipid Profile(60 days)
- fasting blood glucose(60 days)
- Glycated hemoglobin(60 days)
- Glycosylated albumin(60 days)
- skeletal muscle mass(60 days)
- waist to hip ratio (WHR)(60 days)
- Body Mass Index BMI(60 days)
- body weight(60 days)
Investigators
Zhijun Bao
Director
Fudan University