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

NCT ID: NCT03248414

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-10

Study Completion Date

2018-09-10

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double blinded

Study Groups

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Lactobacillus sakei

2 packs per day

Group Type EXPERIMENTAL

Lactobacillus sakei

Intervention Type DIETARY_SUPPLEMENT

1 pack contained 5 x 109 cfu

Control

2 packs per day

Group Type PLACEBO_COMPARATOR

Lactobacillus sakei

Intervention Type DIETARY_SUPPLEMENT

1 pack contained 5 x 109 cfu

Interventions

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Lactobacillus sakei

1 pack contained 5 x 109 cfu

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32615727 (View on PubMed)

Other Identifiers

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B-1511/324-002

Identifier Type: -

Identifier Source: org_study_id

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