## Protocol Section
### Identification Module
**NCT ID:** NCT06422013

**Brief Title:** Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of GTB1

**Official Title:** 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)

#### Organization Study ID Info
**ID:** AP-PV-2022-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Amorepacific Corporation
### Status Module
#### Completion Date
**Date:** 2023-12-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-08

**Type:** ACTUAL

#### Start Date
**Date:** 2022-10-28

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Amorepacific Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

**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.

### Conditions Module

**Conditions:**

- Body Fat

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Once-daily, once a packet, for 12 week

**Intervention Names:**

- Dietary Supplement: GTB1

**Label:** GTB1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Once-daily, once a packet, for 12 week

**Intervention Names:**

- Dietary Supplement: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GTB1

**Description:** oral administration of GTB1 powder packet once daily

**Name:** GTB1

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** oral administration of placebo powder packet once daily

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement is made using dual-energy X-ray absorptiometry(DEXA)

**Measure:** Changes of percent body fat(trunk, total ect.)

**Time Frame:** Baseline, Week 12

#### Secondary Outcomes

**Description:** Measurement of the target area is made using dual-energy X-ray absorptiometry (DEXA)

**Measure:** Changes of fat free mass(trunk, total ect.)

**Time Frame:** Baseline, Week 12

**Description:** Measurement of the target area is made using computed tomography (CT)

**Measure:** Changes of total abdominal fat area, visceral fat area and subcutaneous fat area

**Time Frame:** Baseline, Week 12

**Description:** Measurement of waist and hip circumference is performed following the WHO guideline

**Measure:** Changes of waist, hip circumference and waist/hip circumference ratio

**Time Frame:** Baseline, Week 12

**Description:** Indicator of lipid metabolism(i.e., Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol)

**Measure:** Changes of indicator of lipid metabolism

**Time Frame:** Baseline, Week 12

**Description:** Obesity-related hormone indexes(Adiponectin, Leptin etc.). As blood adiponectin levels increase, blood leptin concentrations decrease, indicating a positive change.

**Measure:** Changes of obesity-related hormone index

**Time Frame:** Baseline, Week 12

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jeonju

**Country:** Korea, Republic of

**Facility:** Jeonbuk National University Hospital

**State:** Jeollabuk-do

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
