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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2022

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.

Interventions

  • Dietary Supplement: Lactobacillus paracasei K56
    • probiotic K56 capsule, 1capsule/day (10^9cfu) ,for 60days
  • Dietary Supplement: placebo
    • placebo capsule(maltodextrin) , 1capsule/day ,for 60days

Arms, Groups and Cohorts

  • Experimental: probiotic K56
    • Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days
  • Placebo Comparator: placebo
    • placebo capsule(maltodextrin, 1capsule/day, 60days

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Collaborator
    • Inner Mongolia Yili Industrial Group Co., Ltd
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhijun Bao, Director – Fudan University
  • Overall Official(s)
    • Ying Feng, Ph.D, Study Director, Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China
  • Overall Contact(s)
    • Ying Feng, Ph.D, +86 18121221972, yingfenghd@hotmail.com

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