A 12 week, Single-center, Randomized, Double-Blind, Placebo-Controlled, Parallel design Clinical Trial for the Evaluation of the Efficacy and safety of Lactiplantibacillus plantarum SKO-001 on Reducing Body Fat
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008871
- Lead Sponsor
- Semyung University Oriental Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of change in body fat percentage (%) after visit 5 (12 week) compared to visit 2 (0 week)
- Secondary Outcome Measures
Name Time Method