None listed
Conditions
Interventions
Dietary Supplement : Oral intake of Test food(HUN2-465) or Placebo food(HUN2-465-R) once a day and once a capsule with water
Sponsors
Huons
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person aged 19 or older and under 60 years of age 2) Those with body mass index (BMI) greater than 25 kg/m² and less than 32 kg/m² on Visit 1 and Visit 2 3) A person who has agreed to participate in this human body application test before the commencement of the human body application test and has written a written consent form
Exclusion criteria
Exclusion criteria: 1) Those currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, psychiatric, musculoskeletal system, infectious disease and malignancy (but may participate in the test at the discretion of the examiner considering the condition of the test subject) 2) A person who has a surgical history through general anesthesia within 6 months based on visit 1 (however, within one year in case of obesity surgery*) * Gastric band plastic surgery, gastrectomy, gastrectomy, etc 3) Obesity or overweight subjects due to endocrine diseases such as hypothyroidism and Cushing's syndrome 4) A person who has used the following drugs (or health functional foods) within one month (30 days) as of visit 1 ? Obesity drugs (food intake inhibitors, fat absorption inhibitors, GLP-1 receptor agonists, etc.) ? psychiatric drugs such as depression and schizophrenia ? Beta blockers, diuretics, steroids (sexual hormones, adrenocortical hormones), contraceptives, thyroid hormones, hormone blockers, immunosuppressants, proton pump inhibitors, hydrogen blockers, aspirin ? Hyperlipid drugs, blood lipids and cholesterol-improving health functional foods [Omega 3 (maintained containing EPA and DHA), ovarian-oxidizing maltodextrin, gamma-linolenic acid, lecithin, plant cholesterol, etc.] ? Health functional foods/supplements and herbal medicines for weight control purposes 5) A person who has administered antibiotics and intestinal medications within two weeks on the basis of visit 1 6) A person who has consumed probiotics, prebiotics, synbiotics, fermented milk and lactobacillus products continuously (more than four times a week) within two weeks of visit 1 7) Subjects who are undergoing continuous treatment or medication due to gastrointestinal disorders (such as gastric ulcer, chronic digestive disorders, irritable bowel syndrome), or who have problems with eating food for human application tests due to gastrointestinal disorders 8) Uncontrolled hypertension patients (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, and measurement criteria after 10 minutes of stabilization of test subjects) 9) Diabetes patients with fasting blood sugar of 126 mg/dL or more or who are on antidiabetic medications (such as oral hypoglycemic agents, insulin, etc.) 10) TSH is outside the normal scope of the implementation agency 11) A person whose eGFR is less than 60 mL/min/1.73 m2 12) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 13) A person who has a history of alcohol abuse or is chronically consuming alcohol* * Drinking alcohol equivalent to an average of 40 g (280 g/week) per day for men and 20 g/week for women (140 g/week) per day for women 14) Excessive smokers (= 20 cigarettes/day) 15) A person who is deemed unable to exercise due to musculoskeletal disorders 16) A person who has had a weight change of 5% or more or 5 kg or more within 3 months as of visit 1 17) A person who has participated in a commercial obesity program within three months based on visit 1 18) A person who has given birth within 6 months based on visit 1, is pregnant, is nursing, or has a pregnancy plan during the main human body application test period 19) A person who has participated in another interventional human body application test (including human body app
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body fat after 12 weeks of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body fat percentage and body fat mass after 12 weeks of intake;Changes in body weight and body mass index after 6 weeks and 12 weeks of intake;Change in waist circumference, hip circumference, and waist/hip circumference ratio after 6 weeks and 12 weeks of intake;Change in total abdominal fat area, visceral fat, subcutaneous fat, visceral fat/subcutaneous fat area ratio after 12 weeks of intake;Changes in blood lipids (Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglyceride) after 12 weeks of intake;Changes in blood indicators (Adiponectin, Leptin, Insulin, HOMA-IR, GOT, GPT) after 12 weeks of intake | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Bum Lee
Global Medical Research Center
Outcome results
None listed