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

July 27, 2020 updated by: Medy-Tox

a Randomised, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam-si, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
capsules that did not contain any probiotics
Experimental: Probiotics
Dietary supplement: LMT1-48
capsules containing Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline and 12-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medy-Tox

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2018

Primary Completion (Actual)

August 17, 2019

Study Completion (Actual)

January 7, 2020

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT13-KR17OWT712

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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