Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
1 other identifier
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2016
CompletedFirst Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2018
CompletedSeptember 11, 2018
September 1, 2018
1.8 years
August 9, 2017
September 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Fat mass change in 12-week
fat mass is measured by DEXA
12 weeks
Secondary Outcomes (6)
Changes in body weight
12 weeks
Changes in waist circumference
12 weeks
Glucose metabolism
12 weeks
Glucose metabolism
12 weeks
Glucose metabolism
12 weeks
- +1 more secondary outcomes
Other Outcomes (1)
GI adverse effect
12 weeks
Study Arms (2)
Lactobacillus sakei
EXPERIMENTAL2 packs per day
Control
PLACEBO COMPARATOR2 packs per day
Interventions
Eligibility Criteria
You may qualify if:
- age 20-65 years
- BMI equal to higher than 25 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (1)
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.
PMID: 32615727DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 14, 2017
Study Start
August 10, 2016
Primary Completion
June 10, 2018
Study Completion
September 10, 2018
Last Updated
September 11, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share