None listed
Conditions
Interventions
Dietary Supplement : Participants in the test group will take one capsule per day containing 500 mg of Wilac D001 (WiKIM51) for 12 weeks.
Participants in the placebo group will take a placebo capsule
Sponsors
Soon Chun Hyang University Hospital Seoul
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged =19 and <65 years 2) Individuals with a body mass index (BMI) =25 kg/m² and <30 kg/m² at both Visit 1 and Visit 2 3) Individuals who voluntarily agree to participate in the clinical trial before its initiation and sign the written Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Individuals that met at least one of the following criteria were excluded: 1) Individuals with a history of cardiovascular (arrhythmia, heart failure, myocardial in-farction, or use of cardiac pacemaker), immune, respiratory, gastrointestinal (Crohn’s disease, bowel resection, irritable bowel syndrome), hepatic or biliary (liver failure, pan-creatic disease), renal or urinary (renal failure), neurologic (including any severity of de-mentia), or cerebrovascular diseases; Individuals with any history of eating disorders, anemia, porphyria, autoimmune diseases, malabsorption syndromes, immunodeficiency, cancer, diseases affecting body weight, infectious diseases, ongoing psychological treat-ment, or uncontrolled diabetes (participation allowed at the investigator’s discretion based on the participant’s condition) 2) Any surgeries within 6 months prior to Visit 1 (within 1 year for bariatric surgeries) 3) Any subcutaneous injections (including heparin and insulin) within 1 year prior to Vis-it 1 4) Weight loss/gain of at least 5 kg or 5% body weight or participation in a weight loss program within 3 months prior to Visit 1 5) Any consumption of the following medications or health/dietary supplements within 3 months prior to Visit 1: a) Anti-obesity drugs or weight loss medications (appetite suppressants, fat absorp-tion inhibitors, GLP-1 receptor agonists, injectable drugs such as Saxenda or Wegovy, etc.) b) Hormone blockers (e.g. tamoxifen) or hormone-blocking therapies used for breast cancer or other conditions) c) Medications or health/dietary supplements related to carbohydrate and lipid me-tabolism, weight control, body fat reduction, fat metabolism, energy metabolism, or appetite suppression) 6) Any consumption of the following medications within 1 month prior to Visit 1: a) Psychiatric medications including antidepressants, antiepileptics, or dementia treatments b) Other medications including diuretics, corticosteroids, hormonal contraceptives, beta-blockers, immunosuppressants, proton pump inhibitors, H2 blockers, non-steroidal anti-inflammatory drugs, or glucose-lowering agents 7) Any antibiotic consumption within 2 weeks prior to Visit 1 8) Any probiotic, prebiotic, synbiotic, or fermented dairy/probiotic products regularly (at least 4 times per week) consumption within 2 weeks prior to Visit 1 9) Individuals with uncontrolled hypertension (systolic greater than 160 mmHg or dias-tolic greater than 110 mmHg, measured after 10 minutes of rest) 10) Individuals with a fasting glucose greater than 126 mg/dL or diabetic patients on anti-diabetic therapy (oral glucose-lowering agents or insulin) 11) Individuals with thyroid-stimulating hormone (TSH) levels outside normal limits 12) Individuals with an estimated glomerular filtration rate (eGFR) lower than 60 mL/min/1.73 m2 13) Individuals with AST (GOT) or ALT GPT) greater than 3 times the upper limit of nor-mal 14) Alcohol consumption above recommended guidelines (male = 40 g per day, female = 20 g per day, based on the WHO daily alcohol intake guidelines) 15) Excessive smoking (= 20 cigarettes per day) 16) Individuals who are unable to perform normal activities of daily living due to muscu-loskeletal disorders 17) Individuals with a history of substance abuse 18) Individuals who are currently pregnant or breastfeeding, have delivered within the past month, or plan to become pregnant during the study period 19) Individuals with sever gastrointestinal disorders than interfere wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body fat mass measured by Dual-energy X-ray Absorptiometry (DEXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body fat percentage and lean body mass;Body weight and body mass index (BMI);Waist and hip circumference, waist-to-hip ratio (W/H ratio);Total, visceral, and subcutaneous abdominal fat area and visceral/subcutaneous fat ratio measured by CT;Serum lipid profile: total cholesterol, HDL, LDL, triglycerides;Hemoglobin A1c (HbA1c);AST(Aspartate Aminotransferase) , ALT (Alanine Aminotransferase) | — |
Countries
Korea, Republic of
Contacts
Public ContactHwayeon Sun
Soon Chun Hyang University Hospital Seoul
Outcome results
None listed