None listed
Conditions
Sponsors
Hecto Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)19year ~ 59year 2) Subject with a BMI of 25kg/m2 or more and 29.9kg/m2 or less 3) Subject who voluntarily agreed in writing to participate in this human application test
Exclusion criteria
Exclusion criteria: 1. Subjects with a body weight change of =5 kg within the past 3 months. 2. Subjects who have undergone surgery within the past 6 months or bariatric surgery within the past 1 year. 3. Subjects with any of the following conditions: * Psychiatric disorders (e.g., depression, schizophrenia) or those who have received psychotherapy * Cardiovascular or cerebrovascular diseases, including arrhythmia, heart failure, myocardial infarction, or history of pacemaker implantation * Diabetes mellitus under pharmacological treatment or uncontrolled diabetes * Hypertension (systolic blood pressure =160 mmHg, diastolic blood pressure >90 mmHg, or currently taking antihypertensive medication) * Gastrointestinal diseases (e.g., Crohn’s disease), history of gastrointestinal resection, or irritable bowel syndrome * Hepatic failure, renal failure, malabsorption syndrome, autoimmune diseases, or cancer * Thyroid disorders or other diseases that may affect body weight * History of anemia, porphyria, pancreatic disease, or eating disorders * Any clinically significant disease that, in the investigator’s judgment, may interfere with study participation 4. Subjects who are pregnant or breastfeeding, or planning to become pregnant during the study period. 5. Female subjects who have given birth within the past 6 months. 6. Subjects with drug abuse or those currently taking the following medications: * Anti-obesity drugs, insulin, antidiabetic agents, diuretics * Corticosteroids, antidepressants, antiepileptic drugs, hormonal contraceptives (for females) * Medications affecting energy metabolism, blood glucose, appetite, or gastrointestinal motility * Medications affecting carbohydrate and lipid metabolism, body weight, or hormonal balance * Immunosuppressants, proton pump inhibitors, H2 receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs) 7. Subjects currently on a continuous diet program within the past 1 year or who have participated in a weight loss program within the past 3 months. 8. Subjects who have received subcutaneous injections (e.g., heparin, insulin) within the past 1 year. 9. Subjects with known allergies or adverse reactions to any components of the investigational or control product. 10. Subjects with alcohol abuse or habitual alcohol intake exceeding: * Males: >40 g/day (approximately 4 glasses of beer or 4 shots of soju) * Females: >20 g/day (approximately 2 glasses of beer or 2 shots of soju) 11. Subjects who are heavy smokers (=20 cigarettes per day). 12. Subjects who have consumed products containing the same or similar ingredients (e.g., probiotic supplements) within the past 1 month. 13. Subjects who have taken medications (including anti-obesity drugs) or health functional foods related to body fat reduction within the past 3 months. 14. Subjects who have participated in other clinical trials within the past 3 months or plan to participate during the study period. 15. Subjects with the following abnormal laboratory findings: * AST or ALT >3× the upper limit of normal * eGFR <60 mL/min/1.73 m² * Thyroid-stimulating hormone (TSH) <0.1 µIU/mL or =10 µIU/mL 16. Subjects deemed unsuitable for study participation by the investigator based on laboratory findings or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in body fat mass (kg) through Dual-Energy X-ray Absorptiometry(DEXA) (Total) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body fat mass by body part (Arm, Leg, Trunk);body fat percentage(%)(Total, Arm, Leg, Trunk);lean mass;Total abdominal fat, visceral fat, subcutaneous fat area;Anthropometric indices (weight, body mass index, waist and hip circumference, waist-to-hip ratio);Lipid-related indicators (Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride, Free fatty acid, Glucose);Metabolic regulatory hormones (Leptin, Adiponectin) | — |
Countries
Korea, Republic of
Contacts
Public ContactYun Yeong Kang
Bestian Seoul Hospital
Outcome results
None listed