None listed
Conditions
Interventions
Dietary Supplement : Test food (immature bitter gourd extract powder) or control food (crystalline cellulose) twice a day (morning and evening), 2 tablets at a time, oral intake
Sponsors
KolmarBNH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person who is 19 years of age or older and 65 years of age or younger 2) Subjects with a body mass index (BMI) greater than or equal to 25 kg/m2 and less than 30 kg/m2 at Visit 1 and Visit 2 3) A person who agrees to participate in the human body application test and fills out an informed consent form before the start of the human body application test
Exclusion criteria
Exclusion criteria: 1) Patients who are currently being treated for severe cardiovascular, immune system, respiratory system, gastrointestinal/hepatic, biliary system, kidney, urinary system, nervous system, psychogenic, infectious diseases, malignant tumors, etc. (However, they can participate in the test at the discretion of the investigator in consideration of the condition of the test subjects) 2) Those who have undergone bariatric surgery within 1 year based on Visit 1 3) Medications that affect body weight within 1 month (30 days) based on Visit 1 {obesity drugs (appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.), psychiatric drugs such as depression and schizophrenia, beta-blockers, diuretics, steroids, thyroid hormones}, hyperlipidemia drugs (including omega-3), health functional foods/supplements for weight control, herbal medicines and weight control formulas, health functional foods that improve blood lipids and cholesterol (fats and fats containing EPA and DHA, indigestible maltodextrin, oils and fats containing gamma-linolenic acid, lecithin, Those who have used phytosterols, etc.) 4) Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, measured after 10 minutes of rest in human body test subjects) 5) Patients with diabetes who have a fasting blood glucose of 126 mg/dL or are taking antidiabetic drugs (oral hypoglycemic drugs, insulin, etc.) 6) Subjects whose TSH is less than or equal to 0.1 µIU/mL or greater than or equal to 10 µIU/mL 7) Creatinine >1.5 mg/dL 8) Those whose AST (GOT) or ALT (GPT) is more than 3 times the normal upper limit of the implementing institution. 9) Persons who have consumed alcohol equivalent to alcohol of more than 210 g/week for males and 140 g/week for females within 1 month based on visit1 10) Those who are judged to be unable to exercise due to musculoskeletal disorders 11) Those who have had a weight change of more than 10% within 3 months based on Visit 1 12) Participants in a commercial obesity program within 3 months of Visit 1 13) Those who have given birth within 6 months of Visit 1, those who are pregnant or lactating, or those who plan to become pregnant during this clinical trial 14) Those who have severe gastrointestinal disorders and have problems with the intake of food for human body testing 15) Participants who have participated in other interventional clinical trials (including clinical trials) within 3 months of Visit 1, or who plan to participate in other interventional clinical trials (including clinical trials) after the start of this clinical trial 16) Those who are sensitive or allergic to the ingredients of the food for this human body application test 17) A person who is judged to be unsuitable by the examiner for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fat mass | — |
Secondary
| Measure | Time frame |
|---|---|
| Body fat percentage, Lean body mass;weight, Body Mass Index;waist, hip circumference, waist/hip circumference;total abdominal fat area, visceral fat, subcutaneous fat, visceral/subcutaneous fat area ratio;blood lipid(Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride);Adiponectin, Leptin;Body elasticity | — |
Countries
Korea, Republic of
Contacts
Public ContactChamin Baek
Global Medical Research Center
Outcome results
None listed