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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192811
• Other study ID #: 20210084
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2021
• Source: Fudan University
• Contact: Ying Feng, Ph.D
• Phone: +86 18121221972
• Email: yingfenghd[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
China	Hua Dong Hospital Affiliated to Fu Dan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Inner Mongolia Yili Industrial Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visceral fat area (cm^2)	VFA (cm^2) will be assessed at baseline and after 60days of intervention	60days
Primary	percent body fat (%)	PBF (%) will be assessed at baseline and after 60days of intervention	60days
Secondary	body weight	Body weight (kg) will be assessed at baseline and after 60days of intervention	60days
Secondary	Body Mass Index BMI	Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention	60 days
Secondary	waist circumference (cm)	will be assessed at baseline and after 60days of intervention	Baseline, 60 days
Secondary	hip circumference(cm)	will be assessed at baseline and after 60days of intervention	60 days
Secondary	waist to hip ratio (WHR)	waist to hip ratio (WHR) will be assessed at baseline and after 60days of intervention	60 days
Secondary	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
Secondary	fasting blood glucose	fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention	60 days
Secondary	Glycated hemoglobin	Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention	60 days
Secondary	Glycosylated albumin	Glycosylated albumin(%) will be measured at baseline and after 60days of intervention	60days