NCT03759743

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

September 4, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

November 14, 2018

Last Update Submit

July 27, 2020

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

  • 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

    at baseline and 12-week follow-up

Study Arms (2)

Probiotics

EXPERIMENTAL
Dietary Supplement: LMT1-48

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

LMT1-48DIETARY_SUPPLEMENT

capsules containing Probiotics

Probiotics
PlaceboDIETARY_SUPPLEMENT

capsules that did not contain any probiotics

Placebo

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 19 and 70 years
  • Overweight (25 kg/m2 ≤ body mass index (BMI) \< 30 kg/m2)

You may not qualify if:

  • Pregnancy or breast-feeding
  • Unstable body weight (body weight change \> 10% within 3 months before screening)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 35487505DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 30, 2018

Study Start

September 4, 2018

Primary Completion

August 17, 2019

Study Completion

January 7, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

KR(1)