None listed
Conditions
Interventions
Dietary Supplement : Subjects is randomly allocated to either experimental or placebo group and take test material(FCCE 1g/day) or placebo twice a day, each time 2 capsules for 12 weeks.
Sponsors
SK bioland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female between 20-65 years 2) BMI=25kg/m^2 and <30kg/m^2 for Visit1 3) Subject who voluntarily agrees to participate and sign in informed consent form
Exclusion criteria
Exclusion criteria: 1) Subject with severe cerebrovascular disease (infarct, hemorrage), cardiac disease (angina, myocardiac infarct, heart failure, arrhythmias that require treatment) within recent 6 months. (If that patient's clinical status is stable, they can participate in the clinical trial according to investigator) 2) Patients with uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 100 mmHg, after 10 minutes of test subjects) 3) Subjects who fasting blood glucose = 126 mg/dL or random blood glucose= 200 mg/dL or diabetic patients use of hypoglycemic agent or insulin 4) Subject who TSH = 0.1 µU/ml or = 10 µU/ml 5) Subject who eGFR < 60 mL/min/1.73? 6) Subject who more than 3times the upper limit of normal AST(GOT) or ALT(GPT) of clinical trial institution 7) Subject with severe gastrointestinal disorders that have a problem with taking test material 8) Subject who was taking drugs that affect body weight within the past month (including absorption inhibitors and appetite suppressants, health functional foods / supplements related to obesity improvement, psychiatric drugs such as depression, beta blockers, diuretics, birth control pills, steroids) 9) Subject who participated in the commercial obesity program within the last 3 months 10) Subject who have participated or planned to participate in other clinical trials within the past month 11) Subject who are admitted to hospital, medication or rehabilitation due to alcohol use disorder ? related disorder, heart disease, central nervous disorder, etc. through medical history 12) Subject who are judged to be unable to exercise due to musculoskeletal disorders 13) Subject who is pregnant or is lactating or has a pregnancy plan during the period of the clinical trial 14) Subject who the opinion investigator make a judgment to be unsuitable for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Body Fat by DEXA(Dual-energy X-ray absorptiometry) | — |
Secondary
| Measure | Time frame |
|---|---|
| weight;Waist Circumference, Hip Circumferenc, Waist to Hip Ratio;Body Mass Index(BMI);Fat mass, Lean Mass by DEXA(Dual-energy X-ray absorptiometry);Visceral Fat Area, Subcutaneous Fat Area, Taoal Fat Area,Visceral fat / Subcutanesou Fat Ratio by CT;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;Adiponectin, hs-CRP, Leptin;treatment-emergent adverse events(TEAEs);clinical laboratory test(hematologic/chemistry examination, Urinalysis);Vital Sign(pulsus, arteriotony) | — |
Countries
Korea, Republic of
Contacts
Public ContactJungha Kim
Chung-Ang Univerisity Hospital
Outcome results
None listed