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

Evaluation of the Effects of a Probiotic Strain Lactobacillus Paracasei K56 on Body Fat Reduction in Middle-aged Obese Subjects：A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Lactobacillus paracasei K56; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Feng, Ph.D; Phone Number: +86 18121221972; Email: yingfenghd@hotmail.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Hua Dong Hospital Affiliated to Fu Dan University
    • Contact: Ying Feng, Ph.D; Phone Number: +86 18121221972; Email: yingfenghd@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: probiotic K56; Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days	Dietary supplement: Lactobacillus paracasei K56; probiotic K56 capsule, 1capsule/day (10^9cfu) ,for 60days
Placebo Comparator: placebo; placebo capsule(maltodextrin, 1capsule/day, 60days	Dietary supplement: placebo; placebo capsule(maltodextrin) , 1capsule/day ,for 60days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visceral fat area (cm^2)	VFA (cm^2) will be assessed at baseline and after 60days of intervention	60days
percent body fat (%)	PBF (%) will be assessed at baseline and after 60days of intervention	60days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	Body weight (kg) will be assessed at baseline and after 60days of intervention	60days
Body Mass Index BMI	Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention	60 days
waist circumference (cm)	will be assessed at baseline and after 60days of intervention	Baseline, 60 days
hip circumference(cm)	will be assessed at baseline and after 60days of intervention	60 days
waist to hip ratio (WHR)	waist to hip ratio (WHR) will be assessed at baseline and after 60days of intervention	60 days
Serum Lipid Profile	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	60 days
fasting blood glucose	fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention	60 days
Glycated hemoglobin	Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention	60 days
Glycosylated albumin	Glycosylated albumin(%) will be measured at baseline and after 60days of intervention	60days

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Inner Mongolia Yili Industrial Group Co., Ltd
• Investigators: Study Director: Ying Feng, Ph.D, Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: obesity; gut microbiota; visceral fat area; body fat; lactobacillus paracasei
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 20210084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No