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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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