Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study

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 before-after pilot study, the participants were randomly assigned to 8 groups to compare the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing different product prototypes , and screen the best probiotic K56 prototype with the effect of fat reduction.

Study Overview

• Status: Completed
• Conditions: Obesity; Adiposity
• Intervention / Treatment: Dietary supplement: probiotic drink with Lactobacillus paracasei K56; Dietary supplement: maltodextrin; Dietary supplement: Probiotic powder E3; Dietary supplement: Probiotic powder E5; Dietary supplement: probiotic capsule E7; Dietary supplement: probiotic capsule E9; Dietary supplement: probiotic capsule E10; Dietary supplement: probiotic capsule E11

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Hua Dong Hospital Affiliated to Fu Dan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI>=30kg/m2,or percent of body fat(PBF) >=25% for male, >=30 for female.
• Age: 18 - 60 years old adults

Exclusion Criteria:

• patients with severe chronic diseases (coronary heart disease, diabetes, hypertension, immune deficiency, mental disorders, tumors, liver and kidney dysfunction, etc.) and complications;irritable bowel syndrome
• 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
• 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: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: K56 very high dose -E1; Probiotic drink (lactobacillus paracasei K56 10^11CFU) 350ml/d , for 60days	Dietary supplement: probiotic drink with Lactobacillus paracasei K56; Probiotic drink (K56 10^11CFU) 350ml/d for 60days
Placebo Comparator: control -E2; maltodextrin , for 60days	Dietary supplement: maltodextrin; maltodextrin ,for 60days
Active Comparator: K56 high dose-E3; Probiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10^10cfu) , for 60days	Dietary supplement: Probiotic powder E3; Probiotic powder 3.0g/d (K56 10^10cfu) 60days;
Active Comparator: K56 middle dose-E5; Probiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10^9cfu) , for 60days	Dietary supplement: Probiotic powder E5; probiotic powder 8g/day for 60days
Active Comparator: K56 low dose -E7; probiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10^7cfu) , for 60days	Dietary supplement: probiotic capsule E7; probiotic k56 capsule, 2capsules/d (10^7cfu) for 60days
Active Comparator: K56 middle dose-E9; probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^9cfu) ,for 60days	Dietary supplement: probiotic capsule E9; probiotic k56 capsule, 2capsules/d (10^9cfu) for 60days
Active Comparator: K56 high dose-E1K; probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^10cfu), for 60days	Dietary supplement: probiotic capsule E10; probiotic k56 capsule, 2capsules/d (10^10cfu) for 60days
Active Comparator: K56 very high dose-E11; probiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10^11cfu) ,for 60days	Dietary supplement: probiotic capsule E11; probiotic k56 capsule, 4capsules/d (10^11cfu) for 60days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index BMI	Body Mass Index (kg/m^2) 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	60 days
skeletal muscle mass	skeletal muscle mass (kg) will be assessed at baseline and after 60days of intervention	60 days
body weight	Body weight (kg) will be assessed at baseline and after 60days of intervention	60 days

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): January 10, 2021
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: July 1, 2021

More Information

Terms related to this study

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

Drug and device information, study documents

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