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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

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Lactobacillus sakei Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Actual Study Start Date : August 10, 2016
Actual Primary Completion Date : June 10, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactobacillus sakei
2 packs per day
Dietary Supplement: Lactobacillus sakei
1 pack contained 5 x 109 cfu

Placebo Comparator: Control
2 packs per day
Dietary Supplement: Lactobacillus sakei
1 pack contained 5 x 109 cfu




Primary Outcome Measures :
  1. Fat mass change in 12-week [ Time Frame: 12 weeks ]
    fat mass is measured by DEXA


Secondary Outcome Measures :
  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 Outcome Measures:
  1. GI adverse effect [ Time Frame: 12 weeks ]
    incidence of gastrointestinal discomfort



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248414


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03248414    
Other Study ID Numbers: B-1511/324-002
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms