search
Back to results

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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lactobacillus paracasei K56
placebo
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, lactobacillus paracasei, body fat, visceral fat area, gut microbiota

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hua Dong Hospital Affiliated to Fu Dan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

probiotic K56

placebo

Arm Description

Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days

placebo capsule(maltodextrin, 1capsule/day, 60days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2021
Last Updated
December 30, 2021
Sponsor
Fudan University
Collaborators
Inner Mongolia Yili Industrial Group Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT05192811
Brief Title
The Effect of Intervention With Probiotic K56 on Body Fat Reduction in Obese Subjects
Official Title
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
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Inner Mongolia Yili Industrial Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, lactobacillus paracasei, body fat, visceral fat area, gut microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
probiotic K56
Arm Type
Experimental
Arm Description
Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsule(maltodextrin, 1capsule/day, 60days
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus paracasei K56
Intervention Description
probiotic K56 capsule, 1capsule/day (10^9cfu) ,for 60days
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo capsule(maltodextrin) , 1capsule/day ,for 60days
Primary Outcome Measure Information:
Title
visceral fat area (cm^2)
Description
VFA (cm^2) will be assessed at baseline and after 60days of intervention
Time Frame
60days
Title
percent body fat (%)
Description
PBF (%) will be assessed at baseline and after 60days of intervention
Time Frame
60days
Secondary Outcome Measure Information:
Title
body weight
Description
Body weight (kg) will be assessed at baseline and after 60days of intervention
Time Frame
60days
Title
Body Mass Index BMI
Description
Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention
Time Frame
60 days
Title
waist circumference (cm)
Description
will be assessed at baseline and after 60days of intervention
Time Frame
Baseline, 60 days
Title
hip circumference(cm)
Description
will be assessed at baseline and after 60days of intervention
Time Frame
60 days
Title
waist to hip ratio (WHR)
Description
waist to hip ratio (WHR) will be assessed at baseline and after 60days of intervention
Time Frame
60 days
Title
Serum Lipid Profile
Description
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
Time Frame
60 days
Title
fasting blood glucose
Description
fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention
Time Frame
60 days
Title
Glycated hemoglobin
Description
Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention
Time Frame
60 days
Title
Glycosylated albumin
Description
Glycosylated albumin(%) will be measured at baseline and after 60days of intervention
Time Frame
60days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Feng, Ph.D
Phone
+86 18121221972
Email
yingfenghd@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Feng, Ph.D
Organizational Affiliation
Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China
Official's Role
Study Director
Facility Information:
Facility Name
Hua Dong Hospital Affiliated to Fu Dan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Feng, Ph.D
Phone
+86 18121221972
Email
yingfenghd@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs