Human trial to evaluate the efficacy and safety of Aronia melanocarpa extract on decrease of body fat
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003672
- Lead Sponsor
- Wonkwang University, Gwangju Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
1)An adult male and female over the age of 20 and under 65 at the time of screening.
2)Those with a BMI of 23 kg/m2 or higher at the time of screening, with a body fat rate of 25 % for males and 30% for females
3) Those who have heard the full explanation of this human application test, fully understand it, and have voluntarily decided to participate and have agreed in writing to comply with the precautions.
1)Those who have lost more than 10% of their weight within 3 months prior to screening
2)A person of high obesity
3)Products that affect weight within one month of the screening test are being taken (concomitant medication references) with improved body fat health food or medicines, contraceptives, steroids, and female hormones).
4)Persons with clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, interdialogal system, kidney and urinary machinery, nervous system, musculoskeletal system, inflammatory and blood · tumor disease, gastrointestinal diseases, etc.
5)Diabetic patients with oral hypoglycemic agents or insulin injections (as at the time of the subject's screening)
6)A person who has a history of clinically significant hypersensitivity in the ingredient of aronia.
7)Those who have had experience in antipsychotic medication within three months prior to screening.
8)Someone who has or is suspected of drug abuse.
9)Those who participated in other human application tests within one month prior to the screening test.
10)Persons with 180 mmHg of systolic blood pressure and 110 mmHg or more of loosening blood pressure.
11)A menopause woman
12)Those whose diagnostic examination shows the following results :
-AST, ALT> three times the upper limit of the reference range
-Serum Creatinine > 2.0 mg/dL
13)A pregnant or breast-feeding woman.
14)where appropriate contraception has not been accepted among fertile women.
15)Diagnostic test A person who is determined by the Principal inspector to be ineligible for research due to medical examination results or other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body fat mass measured by Dual energy X-ray absorptiometry,DEXA
- Secondary Outcome Measures
Name Time Method Percent Body fat and Fat Free Mass measured by Dual energy X-ray absorptiometry,DEXA;Body fat related index: Lipid accumulation product(LAP);Geological Metrics: Total cholesterol;Body fat related index : Visceral Adiposity Index(VAI);Geological Metrics :Triglyceride;Geological Metrics : Low-Density Lipoprotein Cholesterol(LDL-C);Geological Metrics : High-Density Lipoprotein Cholesterol(HDL-C);Geological Metrics :Non High-Density Lipoprotein Cholesterol(Non HDL-C);Adverse events;Diagnostic examination;Vital signs;Physical examination;Electrocardiogram