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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980599
• Other study ID #: ZBao
• Status: Completed
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 31, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Obesity

Intervention

Dietary Supplement:
• probiotic drink with Lactobacillus paracasei K56
Probiotic drink (K56 10^11CFU) 350ml/d for 60days
• maltodextrin
maltodextrin ,for 60days
• Probiotic powder E3
Probiotic powder 3.0g/d (K56 10^10cfu) 60days;
• Probiotic powder E5
probiotic powder 8g/day for 60days
• probiotic capsule E7
probiotic k56 capsule, 2capsules/d (10^7cfu) for 60days
• probiotic capsule E9
probiotic k56 capsule, 2capsules/d (10^9cfu) for 60days
• probiotic capsule E10
probiotic k56 capsule, 2capsules/d (10^10cfu) for 60days
• probiotic capsule E11
probiotic k56 capsule, 4capsules/d (10^11cfu) 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	percent body fat	percent body fat (%) will be assessed at baseline and after 60days of intervention	60days
Primary	visceral fat area	visceral fat area (cm^2) will be assessed at baseline and after 60days of intervention	60days
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	60 days
Secondary	skeletal muscle mass	skeletal muscle mass (kg) 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	Body Mass Index BMI	Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention	60 days
Secondary	body weight	Body weight (kg) will be assessed at baseline and after 60days of intervention	60 days