Efficacy and safety of ASE(Aster spathulifolius Maxim. extract) on reducing body weight and body fat in overweight subjects
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002664
- Lead Sponsor
- ewtree
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
(1) Adult men and women aged 20 or older and younger than 70 years
(2) Those with a body mass index (BMI) of 23 kg / m2 or more and less than 30 kg / m2
(3) A person who agrees to participate in the Applicable Human Body Examination and who has voluntarily signed a written consent form (or legal representative)
(1) Subjects with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment) within the last 6 months If the subject has a history but is clinically stable, he or she can participate in the test by the examiner's judgment.)
(2) Uncontrolled hypertension patients (blood pressure of 160/100 mmHg or more, after 10 minutes of test subjects)
(3) Diabetic patients taking fasting blood glucose levels greater than 126 mg / dl, randomized blood glucose levels greater than 200 mg / dl, or taking oral hypoglycemic agents or insulin
(4) TSH not more than 0.1 uU / ml or not less than 10 uU / ml
(5) Creatinine is at least twice the normal upper limit of the testing laboratory
(6) AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the test laboratory.
(7) People who complain of severe gastrointestinal symptoms such as heartburn and indigestion
(8) 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, Who are taking medicines to treat hyperlipidemia
(9) Those who participated in the commercial obesity program within the last 3 months
(10) Have participated or planned to participate in other clinical trials within the past month
(11) Those who are admitted to hospital, medication or rehabilitation due to heart disease, central nervous disorder, etc. through medical history
(12) A person who is judged to have trouble with the test due to excessive alcohol consumption
(13) Those who are judged to be unable to exercise due to musculoskeletal disorders
(14) A person who is pregnant or who has a pregnancy plan during the period of the test
(15) Any person who is found to be unsuitable for any other reason
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in body fat through DEXA(Dual Energy X-Ray Absorptiometry) after 12 weeks compared to baseline;Changes in visceral fat area, subcutaneous fat area, total abdominal fat area, visceral / subcutaneous fat area ratio by CT after 12 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method Body weight, body fat mass through bio-impedance devices;Waist circumference, hip circumference, waist / hip circumference ratio;body mass index;Body fat through DEXA(Dual Energy X-Ray Absorptiometry) ;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;hs-CRP, Fasting insulin, HOMA-IR, HOMA-ß;leptin, adiponectin, TNF-a, IL-6