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Completed

NCT Number: NCT03248414

Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects

In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 20-65 years
  • BMI equal to higher than 25 kg/m2

Exclusion criteria

  • under anti-obesity medication
  • uncontrolled diabetes
  • uncontrolled hypertension
  • any medications can influence to body weight such as thiazolidinedione, GLP-1 analogue, SGLT2 inhibitor, diuretics
  • thyroid function test abnormality
  • malignancy within 5 years
  • immune compromised hosts or under immune suppressants
  • antibiotics or probiotics withing 2 weeks
  • any intervention to reduce body weight within 6 months

Treatment and study plan

Lactobacillus sakei

Dietary Supplement

1 pack contained 5 x 109 cfu

Primary outcomes

  1. Fat mass change in 12-week

    Time frame: 12 weeks

    fat mass is measured by DEXA

Secondary outcomes

  1. Changes in body weight

    Time frame: 12 weeks

    body weight change

  2. Changes in waist circumference

    Time frame: 12 weeks

    Waist circumference change

  3. Glucose metabolism

    Time frame: 12 weeks

    Changes in HbA1c

  4. Glucose metabolism

    Time frame: 12 weeks

    Changes in fasting glucose concentration

  5. Glucose metabolism

    Time frame: 12 weeks

    Changes in insulin resistance

  6. Glucose metabolism

    Time frame: 12 weeks

    Changes in beta-cell function

Other outcomes

  1. GI adverse effect

    Time frame: 12 weeks

    incidence of gastrointestinal discomfort

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2017
Registry last updated
Sep 11, 2018

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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