A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Lactobacillus plantarum LMT1-48 on Reducing Body Fat
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008055
- Lead Sponsor
- Global Medical Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1) A person who is 19 years of age or older and under 70 years of age
2) Those with a body mass index (BMI) of 25 kg/m² or more and less than 30 kg/m² for visit 1 and visit 2
3) A person who agrees to participate in the human body application test and prepares a written consent form before the human body application test begins
1) Serious cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary tract, kidney and urinary system, nervous system, mental,
A person who is currently being treated for infectious diseases, etc. (However, he/she may participate in the test at the discretion of the tester considering the condition of the person subject to the human body application test)
2) Those diagnosed with cancer within 5 years as of Visit 1 (excluding thyroid cancer, early cervical cancer (endothelial cancer))
3) Within 1 month (30 days) of visit 1, weight-affecting drugs (such as appetite suppressants, liposuction inhibitors, GLP-1 receptor agonists), psychiatric drugs such as depression and schizophrenia, beta-blockers, diuretics, contraceptives, thyroid hormones), hyperlipidemia drugs (including omega3), health-controlled, phytosanitary and dietary supplements
4) A person who has administered antibiotics and intestinal medications within two weeks as of Visit 1
5) A person who has administered or ingested probiotics, prebiotics, and lactobacillus products continuously (more than 4 times a week) within 2 weeks as of Visit 1
6) A person who has undergone obesity surgery within one year based on visit 1
7) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more, measured after stabilization for 10 minutes)
8) Diabetes patients who have an empty stomach blood sugar of 126 mg/dL or higher or who are taking anti-diabetic drugs (e.g., oral hypoglycemic drugs, insulin, etc.)
9) Those with a TSH of not more than 0.1 µIU/mL or not more than 10 µIU/mL
10) A person whose creatinine is twice or more than the upper limit of the institution's normal limit
11) A person whose AST (GOT) or ALT (GPT) is three times or more than the upper limit of the normal limit of the implementing institution;
12) Alcohol use ? People with induced or central nervous disorders
13) A person who is deemed unable to exercise due to musculoskeletal disorders
14) A person who has experienced a weight change of 10% or more within 3 months as of Visit 1
15) A person who has participated in a commercial obesity program within three months as of Visit 1
16) A person who has participated in other interventional clinical trials (including human application tests) within 3 months of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of the personal application test
17) A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
18) A person who has a problem with food intake for human body application tests due to severe gastrointestinal disorders
19) A person who is sensitive to or allergic to food ingredients for this human body application test
20) A person who judges that the tester is inappropriate for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method body fat through DEXA
- Secondary Outcome Measures
Name Time Method body weight;body mass index(BMI);thigh, arm, waist, hip circumference, waist/hip circumference;fat through DEXA;visceral fat, subcutaneous fat, total abdominal fat area, visceral/subcutaneous fat area ratio through CT;blood lipid(Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride, Free Fatty Acid);Adiponectin;a fecal germ gun