Investigation of Anti-obesity Properties of Lactobacillus... | NCT03248414

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

NCT03248414

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Sep 11, 2018Actual

Enrollment

114Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Lactobacillus sakei

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2016Actual

Primary Completion Date

Jun 10, 2018Actual

Completion Date

Sep 10, 2018Actual

First Submitted Date

Aug 9, 2017

First Submission Date that Met QC Criteria

Aug 9, 2017

First Posted Date

Aug 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2018

Last Update Posted Date

Sep 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo Lim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactobacillus sakei	Experimental	2 packs per day	Dietary Supplement: Lactobacillus sakei
Control	Placebo Comparator	2 packs per day	Dietary Supplement: Lactobacillus sakei

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactobacillus sakei	Dietary Supplement	1 pack contained 5 x 109 cfu	Control Lactobacillus sakei

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fat mass change in 12-week	fat mass is measured by DEXA	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in body weight	body weight change	12 weeks
Changes in waist circumference	Waist circumference change	12 weeks

Other Outcomes

Measure	Description	Time Frame
GI adverse effect	incidence of gastrointestinal discomfort	12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32615727	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases