None listed
Conditions
Interventions
Dietary Supplement : Investigational product name: Lactiplantibacillus plantarum SKO-001
Main ingredient name: Lactiplantibacillus plantarum SKO-001
Properties: white hard capsule with no off-flavor
S
Sponsors
Semyung University Oriental Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between the ages of 19 and 65 2) Subjects with a body mass index of 25.0 kg/m^2 or more and less than 30.0 kg/m^2 3) Subjects who voluntarily decides to participate in this study and signs the Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) Participants with a history of hypersensitivity to drugs, food ingredients, herbal extracts, dietary supplements, or lactobacillus 2) Participants currently undergoing treatment for severe cardiovascular, immune, respiratory, hepatomegaly, kidney and urinary system, nervous system, musculoskeletal system, psychotropic diseases and malignant tumors 3) Participants who are consuming prebiotics, probiotics, and postbiotics similar to this investigational product within 4 weeks prior to screening 4) Participants who have had participated in a commercial obesity program or treatment program for weight loss within the last three months prior to screening 5) Participants taking drugs (absorption inhibitors, appetite suppressants, beta Blockers, GLP-1 receptor agonist, health functional foods/supplements related to obesity improvement, psychiatric drugs such as depression, diuretics, contraceptives, steroids, female hormones) or diet foods that affect their weight within 3 months prior to screening 6) Participants with weight change of at least 10% within 3 months prior to screening 7) Participants who had undergone surgery such as gastronomy, intestinal resection, or other surgical procedures for weight loss within 6 months prior to screening 8) 9) Participants who have liver disease or whose ALT or AST is more than 3 times the upper limit of normal 10) Participants who have renal disease or whose creatinine level is more than twice the upper limit of normal 11) Patients with uncontrolled hypertension(blood pressure over 160/100 mmHg or if medication has been changed or started anew due to hypertension within 3 months) 12) Participants who have a fasting blood sugar level of 126 mg/dl or higher, have been diagnosed with diabetes, or are taking oral hypoglycemic agents or insulin 13) Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion 14) Participants with a history of serious psychiatric illness (schizophrenia, epilepsy, anorexia, bulimia, etc.) or alcohol or the other drug abuse 15) Participants who are determined to be unable to exercise due to musculoskeletal disorders 16) Women who are pregnant, lactating, or planning to become pregnant during the trial 17) Participants who has a history of having participated in another trial or taking a test drug within 3 months prior to screening 18) Participants who are deemed inappropriate to participate in this study by the principal investigator (or delegated subinvestigator) for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in body fat percentage (%) after visit 5 (12 week) compared to visit 2 (0 week) | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of change in body fat mass (g) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in lean body mass (g) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in visceral fat area (cm^2) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in subcutaneous fat area (cm^2) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in total fat area (cm^2) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in visceral fat area/subcutaneous fat area ratio (VSR) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in body weight (kg) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in body mass index (BMI) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in waist circumference (cm) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in hip circumference (cm) after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in waist circumference/hip circumference ratio after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in Total cholesterol after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in Triglyceride after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in HDL-Cholesterol after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in LDL-Cholesterol after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in Adiponectin after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in Leptin after visit 5 (12 week) compared to visit 2 (0 week);Amount of change in Insulin after visit 5 (12 week) compared to visit 2 (0 week) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeonMi Shin
Semyung University
Outcome results
None listed