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

Not Applicable

Completed

• Conditions: Obesity; Adiposity
• Interventions: Dietary Supplement: probiotic capsule E10; Dietary Supplement: probiotic drink with Lactobacillus paracasei K56; Dietary Supplement: probiotic capsule E11; Dietary Supplement: probiotic capsule E9; Dietary Supplement: maltodextrin; Dietary Supplement: Probiotic powder E3; Dietary Supplement: Probiotic powder E5; Dietary Supplement: probiotic capsule E7

• Registration Number: NCT04980599
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-10
• Status Verified: 2021-07
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-28
• Primary Completion: 2021-08-30
• Study Completion: 2021-12-31
• Last Update Submitted: 2023-01-08
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K56 high dose-E1K	probiotic capsule E10	probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10\^10cfu), for 60days
K56 very high dose -E1	probiotic drink with Lactobacillus paracasei K56	Probiotic drink (lactobacillus paracasei K56 10\^11CFU) 350ml/d , for 60days
K56 very high dose-E11	probiotic capsule E11	probiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10\^11cfu) ,for 60days
K56 middle dose-E9	probiotic capsule E9	probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10\^9cfu) ,for 60days
control -E2	maltodextrin	maltodextrin , for 60days
K56 high dose-E3	Probiotic powder E3	Probiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10\^10cfu) , for 60days
K56 middle dose-E5	Probiotic powder E5	Probiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10\^9cfu) , for 60days
K56 low dose -E7	probiotic capsule E7	probiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10\^7cfu) , for 60days

Primary Outcome Measures

Name	Time	Method
visceral fat area	60days	visceral fat area (cm\^2) will be assessed at baseline and after 60days of intervention
percent body fat	60days	percent body fat (%) will be assessed at baseline and after 60days of intervention

Secondary Outcome Measures

Name	Time	Method
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
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	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
waist to hip ratio (WHR)	60 days	waist to hip ratio (WHR) will be assessed 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

Trial Locations

Locations (1)

Hua Dong Hospital Affiliated to Fu Dan University; 🇨🇳 Shanghai, China