Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of GTB1

A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of Lactiplantibacillus Plantarum APsulloc 331261(GTB1)

This study was conducted to investigate the effects of daily supplementation of GTB1 on decrease of body fat.

Study Overview

• Status: Completed
• Conditions: Body Fat
• Intervention / Treatment: Dietary supplement: GTB1; Dietary supplement: Placebo

Detailed Description

This study was a 12 week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into GTB1 group and placebo group. It is to evaluate the changes in the displayed evaluation items when taking GTB1 once a day, in comparison with taking a placebo.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of
      • Jeonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Males and females aged between 19~65 years at the screening
• Participants who were BMI 25.0~34.9 kg/m^2 (Excluding those who need to take or be prescribed medication that affects fat reduction, if the BMI is between 30.0~34.9 kg/m^2)
• Participants who have a waist circumference of 90 cm for men and 85 cm or more for women
• Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions

Exclusion Criteria:

• Participants who decrease 10% more of weight within 3 months period to the screening
• Participants who have undergone surgical procedures (such as gastrectomy) for weight loss
• Participants who have a history of malignant tumors within 5 years prior to participating in the clinical study
• Participants who have a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 100 mmHg or higher (those who are stably controlling their blood pressure with medication can participate)
• Participants who are taking beta-blockers or diuretics as part of their hypertension treatment
• Patients who have been diagnosed with Type 1 or Type 2 diabetes and are taking oral hypoglycemic agents and insulin
• Participants who have taken antibiotics within 4 weeks prior to the screening examination
• Participants who have taken health functional foods, herbal medicine, or general foods for the purpose of weight loss within 4 weeks prior to the screening visit
• Participants with clinically significant acute or chronic diseases of the cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic, gastrointestinal diseases, and other diseases requiring treatment
• Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial
• Participants who have participated in other clinical study within 3 months prior to the screening examination
• Women who are pregnant or breastfeeding
• Women who may become pregnant and have not used appropriate contraceptives

• Participants who show the following relevant results in a Laboratory test

  • Aspartate Transaminase (AST), Alanine Transaminase (ALT) > Reference range 3 times upper limit
  • Serum Creatinine > 2.0 mg/dl
• Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GTB1; Once-daily, once a packet, for 12 week	Dietary supplement: GTB1; oral administration of GTB1 powder packet once daily
Placebo Comparator: Placebo; Once-daily, once a packet, for 12 week	Dietary supplement: Placebo; oral administration of placebo powder packet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of percent body fat(trunk, total ect.)	Measurement is made using dual-energy X-ray absorptiometry(DEXA)	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of fat free mass(trunk, total ect.)	Measurement of the target area is made using dual-energy X-ray absorptiometry (DEXA)	Baseline, Week 12
Changes of total abdominal fat area, visceral fat area and subcutaneous fat area	Measurement of the target area is made using computed tomography (CT)	Baseline, Week 12
Changes of waist, hip circumference and waist/hip circumference ratio	Measurement of waist and hip circumference is performed following the WHO guideline	Baseline, Week 12
Changes of indicator of lipid metabolism	Indicator of lipid metabolism(i.e., Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol)	Baseline, Week 12
Changes of obesity-related hormone index	Obesity-related hormone indexes(Adiponectin, Leptin etc.). As blood adiponectin levels increase, blood leptin concentrations decrease, indicating a positive change.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Amorepacific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AP-PV-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No