None listed
Conditions
Interventions
Dietary Supplement : The test group or control group shall be randomly allocated and conducted in parallel tests, and the number of subject necessary for the human application test shall be 120 people
Sponsors
NovaKmed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those who are 19 years old or older and 65 years old or younger 2) Those with body mass index (BMI) of 25 kg/m2 or more and less than 32 kg/m2 at Visit 1 and Visit 2 3) Those who have agreed to participate in this human application test before the start of the trial and who have filled out the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) Those who are currently being treated for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychiatric, infectious diseases and malignant tumors, etc. 2) Those who have taken medications that affect body weight{obesity drugs(appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.),psychiatric drugs such as depression medication and schizophrenia medication, beta blockers, diuretics, contraceptives, steroids, female hormones}, health functional foods/supplements for weight control, herbal medicines, and formulas for weight control within 1 month (30 days) based on Visit 1 3) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher, diastolic blood pressure of 100 mmHg or higher, measured after stabilizing of 10 minutes) 4) Diabetic patients whose fasting blood sugar is 126 mg/dL or higher or who are taking antidiabetic drugs (oral hypoglycemic agents, insulin, etc.) 5) Those with TSH of 0.1 µIU/mL or less or 10 µIU/mL or more 6) Those whose creatinine is more than twice the normal upper limit of the testing institution 7) Those whose AST(GOT) or ALT(GPT) is 3 times or more of the normal upper limit of the testing institution 8) Those who have problems with food intake for human application test due to severe gastrointestinal disorders 9) Those with alcohol use-induced disorders and central nervous system disorders 10) Those who are judged unable to exercise due to musculoskeletal disorders 11) Those who had weight changes of 10% or more within 3 months based on visit 1 12) Those who participated in commercial obesity program within 3 months of visit 1 13) Those who have participated in other interventional clinical trials (including human application test) within one month (30 days) of Visit 1, or who are planning to participate in other interventional clinical trials (including human application test) after the start of this trial 14) Those who are pregnant, lactating, or planning to become pregnant during this trial period 15) Those who are sensitive or allergic to the food ingredients of this trial 16) Those who are judged to be inappropriate by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat mass, body fat percentage through DEXA | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight;waist circumference, hip circumference, waist/hip circumference ratio;Body mass Index;Lean mass through DEXA;Visceral fat area, subcutaneous fat area, total abdominal fat area, visceral/subcutaneous fat area ratio through CT;Blood lipid: Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;hs-CRP;Adiponectin;Adverse reaction;Clinical laboratory test(complete blood cell count/admission batt,urinary test);Vital signs(blood pressure, pulse) | — |
Countries
Korea, Republic of
Contacts
Public Contactjaeheon kang
Kangbuk Samsung Medical Center
Outcome results
None listed