None listed
Conditions
Interventions
Dietary Supplement, Others(Hypocaloric diet and taking exercise) : 1. Study food: Sunflower seed extract (SUN-CA, 780mg/tablet, containing 500 mg of the extract)
2. Control food: 780mg/tablet, contain
Sponsors
RP Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects between 19~65 years of age 2. BMI of Visit 1, 2 is placed on =25 kg/m2 and <32kg/m2 3. Subjects who agree the participation in the trial and submit informed consent befthe the beginning of the trial
Exclusion criteria
Exclusion criteria: 1. Subjects with cardiovascular, immune system, respiratory, hepatobiliary, renal, urinary, nervous, skeletal, psychiatric, infectious disease or cancer (If that patient's clinical status is stable, they can participate in the clinical trial according to investigator’s decision.) 2. Subjects who were taking medications that affect body weight within the past 1month (drugs for obesity [including appetite suppressants, lipase inhibitor, GLP-1 receptor agonists], psychiatric drugs such as depression and schizophrenia, beta blockers, diuretics, birth control pills, steroids, female hormone agent), and health functional foods or supplement related to obesity improvement. 3. Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization) 4. Subjects who have fasting blood glucose over 126 mg/dL or diabetic patients using hypoglycemic agent, or insulin. 5. Subjects with abnormal TSH level (If the patients’ clinical status is stable, they can participate in the clinical trial according to investigator’s decision). 6. Subjects with creatinine level more than 2 times upper limit of normal creatinine level of clinical trial institution 7. Subjects with AST or ALT level more than 2 times upper limit of normal AST or ALT level of clinical trial institution 8. Subjects with gastrointestinal disturbances who are suffering from ingestion of the clinical study food. 9. Subjects with alcohol disorders, or disorder of central nervous system 10. Subjects who are determined to unable to exercise due to musculoskeletal disorder 11. Subjects who have had a weight change of 10% of more within the last 3months. 12. Subjects who have participated in a commercial obesity program in the past 3months 13. Subjects who have participated in other interventional clinical trials within 2months of visit 1, or plan to participate in other interventional clinical trials after the start of this clinical trial. 14. Subjects who are pregnant, nursing, or those planning to become pregnant during this clinical trial. 15. Subjects who are sensitive or allergic to SUN-CA. 16. Subjects who are judged that inappropriate to this clinical trial for the other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of body fat amount and body fat % by dual energy X-ray absorptiometry (DEXA);Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiography, urinalysis, and measurements of complete blood count; serum glucose; total bilirubin; aspartate aminotransferase and alanine aminotransferase levels; serum gamma-glutamyl transpeptidase; protein; albumin; creatinine; blood urea nitrogen; uric acid; and serum electrolytes levels such as sodium, potassium, chloride, and calcium ;Body weight;Waist circumference, hip circumference, W/H ratio;Body Mass Index;Lean mass by dual energy X-ray absorptiometry (DEXA);Visceral fat area, subcutaneous fat area, total abdominal fat area, Visceral- / subcutaneous fat ratio;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;High sensitivity C-reactive protein (hs-CRP);Adiponectin, Leptin;Blood pressure, heart rate | — |
Countries
Korea, Republic of
Contacts
Public ContactHa-Na Kim
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed