None listed
Conditions
Interventions
Dietary Supplement : • Experimantal group 1 : Take 1 capsule of low dose Lactobacillus plantarum ATG-K2 twice a day (Lactobacillus plantarum ATG-K2, 4 x 10^9 CFU/day)
• Experimantal group 2 : Take 1
Sponsors
AtoGen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged =19 and <60 years 2. BMI =25 kg/m2 and <30 kg/m2 3. Subjects who voluntarily decide to participate and sign the informed consent after being provided an explanation of this study
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of hypersensitivity to drugs, food ingredients, or lactic-acid bacteria 2. Subjects who have had participated in a commercial weight loss program or other clinical trial within the last three months 3. Subjects taking drugs (absorption inhibitor, appetite suppressant, health functional foods/supplements related to obesity improvement, psychiatric drugs such as depression, diuretics, contraceptives, steroids, or female hormones) or diet foods that affect their weight within three months prior to screening 4. Subjects with intentional weight loss of at least 5% within three months prior to screening 5. Subjects who have undergone surgery, such as gastroplasty and intestinal resection, to lose weight within six months prior to screening 6. Subjects who are obese or overweight due to endocrine diseases such as hypothyroidism and Cushing's syndrome 7. Subjects with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last six months (However, those who are clinically stable may participate in the trial at the investigator's discretion) 8. Subjects with serious dysfunction of the liver (alanine and aspartate aminotransferase levels of 3 times the upper limit of normal) or kidney (creatinine > 2.0 mg/dL) 9. Uncontrolled hypertension patients (blood pressure = 160/100 mmHg or in the case of medication changed or started anew within three months) 10. Uncontrolled diabetic patients (Fasting blood glucose = 180 mg/dL or in the case of medication changed or started anew within three months) 11. Malignant tumor diagnosed within five years prior to screening 12. Pregnant or lactating subjects, or women with pregnancy plan during the study period 13. Subjects who are deemed unsuitable according to the investigator's opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat mass and percent body fat measured by Dual-energy X-ray absorptiometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Visceral fat area, subcutaneous fat area, total abdominal fat area, visceral fat/subcutaneous fat area ratio, skeletal muscle index, and fat liver index measured by abdominal computed tomography;Body weight;Body mass index;waist circumference, hip circumference, waist circumference/hip circumference ratio;blood lipid concentration (total cholesterol; triglyceride, high density lipoprotein cholesterol, and low-density lipoprotein cholesterol);Serum leptin and adiponectin concentrations;Serum Short chain fatty acid and metabolies analysis;Fecal bacterial community;Fasting blood glucose, C-peptide, insulin, homeostasis model assessment of insulin resistance | — |
Countries
Korea, Republic of
Contacts
Public ContactDAE HO LEE
Gachon University Gil Medical Center
Outcome results
None listed