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

Fudan University

Status: Completed

Conditions: Adiposity; Obesity

Treatments: Dietary Supplement: maltodextrin; Dietary Supplement: probiotic capsule E10; Dietary Supplement: Probiotic powder E3; Dietary Supplement: probiotic capsule E11; Dietary Supplement: probiotic drink with Lactobacillus paracasei K56; Dietary Supplement: Probiotic powder E5; Dietary Supplement: probiotic capsule E9; Dietary Supplement: probiotic capsule E7

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04980599

ZBao

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

118 participants in 8 patient groups, including a placebo group

K56 very high dose -E1

Active Comparator group

Description:

Probiotic drink (lactobacillus paracasei K56 10^11CFU) 350ml/d , for 60days

Treatment:

Dietary Supplement: probiotic drink with Lactobacillus paracasei K56

control -E2

Placebo Comparator group

Description:

maltodextrin , for 60days

Treatment:

Dietary Supplement: maltodextrin

K56 high dose-E3

Active Comparator group

Description:

Probiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10^10cfu) , for 60days

Treatment:

Dietary Supplement: Probiotic powder E3

K56 middle dose-E5

Active Comparator group

Description:

Probiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10^9cfu) , for 60days

Treatment:

Dietary Supplement: Probiotic powder E5

K56 low dose -E7

Active Comparator group

Description:

probiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10^7cfu) , for 60days

Treatment:

Dietary Supplement: probiotic capsule E7

K56 middle dose-E9

Active Comparator group

Description:

probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^9cfu) ,for 60days

Treatment:

Dietary Supplement: probiotic capsule E9

K56 high dose-E1K

Active Comparator group

Description:

probiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10^10cfu), for 60days

Treatment:

Dietary Supplement: probiotic capsule E10

K56 very high dose-E11

Active Comparator group

Description:

probiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10^11cfu) ,for 60days

Treatment:

Dietary Supplement: probiotic capsule E11