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

Not Applicable

• Conditions: Obesity
• Interventions: Dietary Supplement: Lactobacillus paracasei K56; Dietary Supplement: placebo

• Registration Number: NCT05192811
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-18
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Study First Posted: 2022-01-14
• Last Update Posted: 2022-01-14
• Primary Completion: 2022-03-30
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic K56	Lactobacillus paracasei K56	Probiotic capsule (lactobacillus paracasei K56 10\^9CFU) 1capsule/day , for 60days
placebo	placebo	placebo capsule(maltodextrin, 1capsule/day, 60days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Body Mass Index BMI	60 days	Body Mass Index (kg/m\^2) will be assessed at baseline and after 60days of intervention
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
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	60days	Glycosylated albumin(%) will be measured at baseline and after 60days of intervention
body weight	60days	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