Back to resultsEvaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LMT1-48
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- Age between 19 and 70 years
- Overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2)
Exclusion Criteria:
- Pregnancy or breast-feeding
- Unstable body weight (body weight change > 10% within 3 months before screening)
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotics
Placebo
Arm Description
Outcomes
Primary Outcome Measures
change from baseline fat percentage at 12 week
the body composition of the subjects was measured via dual-energy X-ray absorptiometry (DEXA) to determine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03759743
Brief Title
Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
Official Title
a Randomised, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
August 17, 2019 (Actual)
Study Completion Date
January 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medy-Tox
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
The purpose of this study is to evaluate the safety and efficacy of LMT1-48(Probiotics) compared to a placebo in reducing the body fat in overweight subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
LMT1-48
Intervention Description
capsules containing Probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
capsules that did not contain any probiotics
Primary Outcome Measure Information:
Title
change from baseline fat percentage at 12 week
Description
the body composition of the subjects was measured via dual-energy X-ray absorptiometry (DEXA) to determine
Time Frame
at baseline and 12-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 19 and 70 years
Overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2)
Exclusion Criteria:
Pregnancy or breast-feeding
Unstable body weight (body weight change > 10% within 3 months before screening)
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
35487505
Citation
Sohn M, Jung H, Lee WS, Kim TH, Lim S. Effect of Lactobacillus plantarum LMT1-48 on Body Fat in Overweight Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial. Diabetes Metab J. 2023 Jan;47(1):92-103. doi: 10.4093/dmj.2021.0370. Epub 2022 Apr 29.
Results Reference
derived
Learn more about this trial
Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
We'll reach out to this number within 24 hrs