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Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759743
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Study Description
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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

Condition or disease Intervention/treatment Phase
Overweight Dietary Supplement: LMT1-48 Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : August 17, 2019
Actual Study Completion Date : January 7, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Probiotics Dietary Supplement: LMT1-48
capsules containing Probiotics
Placebo Comparator: Placebo Dietary Supplement: Placebo
capsules that did not contain any probiotics


Outcome Measures
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Primary Outcome Measures :
  1. change from baseline fat percentage at 12 week [ Time Frame: at baseline and 12-week follow-up ]
    the body composition of the subjects was measured via dual-energy X-ray absorptiometry (DEXA) to determine


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759743


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of
Sponsors and Collaborators
Medy-Tox
More Information
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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03759743    
Other Study ID Numbers: MT13-KR17OWT712
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight