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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248414
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE August 9, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE August 10, 2016
Actual Primary Completion Date June 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
Fat mass change in 12-week [ Time Frame: 12 weeks ]
fat mass is measured by DEXA
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • Changes in body weight [ Time Frame: 12 weeks ]
    body weight change
  • Changes in waist circumference [ Time Frame: 12 weeks ]
    Waist circumference change
  • Glucose metabolism [ Time Frame: 12 weeks ]
    Changes in HbA1c
  • Glucose metabolism [ Time Frame: 12 weeks ]
    Changes in fasting glucose concentration
  • Glucose metabolism [ Time Frame: 12 weeks ]
    Changes in insulin resistance
  • Glucose metabolism [ Time Frame: 12 weeks ]
    Changes in beta-cell function
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 5, 2017)
GI adverse effect [ Time Frame: 12 weeks ]
incidence of gastrointestinal discomfort
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Official Title  ICMJE Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Brief Summary In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction of fat mass assessed by DEXA compared to plaebo.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double blinded
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Dietary Supplement: Lactobacillus sakei
1 pack contained 5 x 109 cfu
Study Arms  ICMJE
  • Experimental: Lactobacillus sakei
    2 packs per day
    Intervention: Dietary Supplement: Lactobacillus sakei
  • Placebo Comparator: Control
    2 packs per day
    Intervention: Dietary Supplement: Lactobacillus sakei
Publications * Lim S, Moon JH, Shin CM, Jeong D, Kim B. Effect of Lactobacillus sakei, a Probiotic Derived from Kimchi, on Body Fat in Koreans with Obesity: A Randomized Controlled Study. Endocrinol Metab (Seoul). 2020 Jun;35(2):425-434. doi: 10.3803/EnM.2020.35.2.425. Epub 2020 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2017)
114
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 10, 2018
Actual Primary Completion Date June 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248414
Other Study ID Numbers  ICMJE B-1511/324-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Soo Lim, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Bundang Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP