Clinical Trial for the Evaluation of the Efficacy and Safety of ETB-F02 on Reducing Body Fat

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0009233
• Lead Sponsor: Enterobiome Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-04-26
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) A person who is 19 years of age or older and 65 years of age or younger
2) Those with a body mass index (BMI) of 25 kg/? or more and less than 30 kg/? in Visit 1 and Visit 2
3) A person who agrees to participate in this human study before the human study begins and prepares a written consent form.

Exclusion Criteria

1) Severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, mental, infectious disease, and malignant tumor can participate in the test at the discretion of the tester.
2) Within one month (30 days) of visit, weight-affecting drugs (obesity drugs, liposuction inhibitors, GLP-1 receptor agents, etc.), psychotropic drugs such as depression and schizophrenia, beta-blockers, diuretics, contraceptives, steroids, female hormones, thyroid hormones), health functional foods/supplements for weight control purposes, and herbal medicine.
3) A person who has used an intestinal medicine within two weeks based on visit 1.
* In the case of systemic steroids and antibiotics, intermittent administration within 7 days for the purpose of transient treatment is possible, but administration within 5 days before the test visit is prohibited.
4) A person who has consumed probiotics, prebiotics, and lactobacillus products continuously (more than four times a week) within two weeks of visiting.
5) A person who has undergone obesity surgery within one year based on visit 1.
6) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest for those subject to human study)
7) Diabetes patients with fasting blood sugar of 126 mg/dL or higher or taking anti-diabetic drugs (such as oral hypoglycemic drugs, insulin, etc.).
8) Those whose TSH is outside the normal range of the implementing institution (however, in consideration of the condition of the person subject to the human study) may participate in the test at the discretion of the tester.)
9) Those with a creatine level of at least twice the normal upper limit of the implementing institution.
10) Those whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the agency.
11) Alcohol use ? Those with induction disorders and central nervous disorders
12) A person who is deemed unable to exercise due to musculoskeletal disorders.
13) A person who has a weight change of 10% or more within three months based on visit 1
14) A person who has participated in a commercial obesity program within 3 months of visiting 1
15) A person who has participated in another interventional clinical trial (including the human study) within 3 months of visit 1 or plans to participate in another interventional clinical trial (including the human study) after the start of this human study
16) A person who is pregnant or who is lactating or has plans to conceive during this human study.
17) A person who has a problem eating food for human study due to severe gastrointestinal disorders
18) A person who is sensitive to or allergic to food ingredients for this human study
19) A person who is deemed inappropriate by the tester for other reasons.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body fat mass and percentage through DEXA

Secondary Outcome Measures

Name	Time	Method
Weight;Body mass index (BMI);Waist circumference, hip circumference, waist/hip circumference ratio;Body fat control through DEXA;body fat and body fat percentage through DEXA(Arms, Legs, Trunk);Visceral fat, subcutaneous fat, total abdominal fat area, and visceral/subcutaneous fat area ratio through CT;blood lipids(Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride);hs-CRP(High-sensitivity C-reactive protein);Insulin;Adiponectin, Leptin;Uncoupling Protein(UCP)1, 2, 3, Peroxisome Proliferator-activated Receptor Gamma Coactivator 1-alpha(PGC-1a);a fecal fungus