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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lactobacillus sakei
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus sakei

Control

Arm Description

2 packs per day

2 packs per day

Outcomes

Primary Outcome Measures

Fat mass change in 12-week
fat mass is measured by DEXA

Secondary Outcome Measures

Changes in body weight
body weight change
Changes in waist circumference
Waist circumference change
Glucose metabolism
Changes in HbA1c
Glucose metabolism
Changes in fasting glucose concentration
Glucose metabolism
Changes in insulin resistance
Glucose metabolism
Changes in beta-cell function

Full Information

First Posted
August 9, 2017
Last Updated
September 9, 2018
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03248414
Brief Title
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Official Title
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2016 (Actual)
Primary Completion Date
June 10, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double blinded
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus sakei
Arm Type
Experimental
Arm Description
2 packs per day
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
2 packs per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus sakei
Intervention Description
1 pack contained 5 x 109 cfu
Primary Outcome Measure Information:
Title
Fat mass change in 12-week
Description
fat mass is measured by DEXA
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in body weight
Description
body weight change
Time Frame
12 weeks
Title
Changes in waist circumference
Description
Waist circumference change
Time Frame
12 weeks
Title
Glucose metabolism
Description
Changes in HbA1c
Time Frame
12 weeks
Title
Glucose metabolism
Description
Changes in fasting glucose concentration
Time Frame
12 weeks
Title
Glucose metabolism
Description
Changes in insulin resistance
Time Frame
12 weeks
Title
Glucose metabolism
Description
Changes in beta-cell function
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
GI adverse effect
Description
incidence of gastrointestinal discomfort
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32615727
Citation
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.
Results Reference
derived

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

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