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OpenTrials
Completed

NCT Number: NCT04980599

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.

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Key information

Conditions

Obesity Adiposity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hua Dong Hospital Affiliated to Fu Dan University

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

probiotic drink with Lactobacillus paracasei K56

Dietary Supplement

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

Maltodextrin

Dietary Supplement

maltodextrin ,for 60days

Probiotic powder E3

Dietary Supplement

Probiotic powder 3.0g/d (K56 10^10cfu) 60days;

Probiotic powder E5

Dietary Supplement

probiotic powder 8g/day for 60days

probiotic capsule E7

Dietary Supplement

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

probiotic capsule E9

Dietary Supplement

probiotic k56 capsule, 2capsules/d (10^9cfu) for 60days

probiotic capsule E10

Dietary Supplement

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

probiotic capsule E11

Dietary Supplement

probiotic k56 capsule, 4capsules/d (10^11cfu) for 60days

Primary outcomes

  1. percent body fat

    Time frame: 60days

    percent body fat (%) will be assessed at baseline and after 60days of intervention

  2. visceral fat area

    Time frame: 60days

    visceral fat area (cm^2) will be assessed at baseline and after 60days of intervention

Secondary outcomes

  1. Serum Lipid Profile

    Time frame: 60 days

    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

  2. fasting blood glucose

    Time frame: 60 days

    fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention

  3. Glycated hemoglobin

    Time frame: 60 days

    Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention

  4. Glycosylated albumin

    Time frame: 60 days

    Glycosylated albumin(%) will be measured at baseline and after 60days of intervention

  5. skeletal muscle mass

    Time frame: 60 days

    skeletal muscle mass (kg) will be assessed at baseline and after 60days of intervention

  6. waist to hip ratio (WHR)

    Time frame: 60 days

    waist to hip ratio (WHR) will be assessed at baseline and after 60days of intervention

  7. Body Mass Index BMI

    Time frame: 60 days

    Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention

  8. body weight

    Time frame: 60 days

    Body weight (kg) will be assessed at baseline and after 60days of intervention

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Inner Mongolia Yili Industrial Group Co., Ltd

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2021
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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