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

NCT ID: NCT06422013

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2023-12-08

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

Body Fat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

GTB1

Once-daily, once a packet, for 12 week

Group Type: ACTIVE_COMPARATOR

GTB1

Intervention Type: DIETARY_SUPPLEMENT

oral administration of GTB1 powder packet once daily

Placebo

Once-daily, once a packet, for 12 week

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

oral administration of placebo powder packet once daily

Interventions

GTB1

oral administration of GTB1 powder packet once daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

oral administration of placebo powder packet once daily

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amorepacific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

AP-PV-2022-01

Identifier Type: -

Identifier Source: org_study_id