When a person takes extract of Gelidium elegans, it is study to evaluate the efficacy and safety
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003514
- Lead Sponsor
- Kyung Hee University Hosipital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1) 80 male and female adults aged 20 years or older who had a body mass index of 25-30 kg / m2 and measured
2) People who have not received medication for obesity within the last 3 months
3) Adults without diabetes
4) A voluntary written consent to participate in the trial
1) Those who are taking medication for obesity within the last 3 months and during the clinical trial
2) Subjective assessment, mental illness that may affect medicines for clinical trials. Especially, psychosis, depression, etc.
3) Exceptions to the following laboratory test results which may affect the performance of the test are excluded.
- A liver disease with AST (SGOT) / ALT (SGPT)> 3 times the upper limit of normal
- a renal impairment with a creatinine level> 1.5 mg / dl
- TSH levels greater than 10
4) Those who have been taking glucocorticoids within the last 3 months that may affect obesity
5) Drug abuse or history (including alcohol)
6) Severe disease history that can be recurred during or immediately after the clinical trial
7) Pregnant and lactating women.
8) In addition, if the researcher is found unable to participate in clinical research
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in body weight.;Changes in body fat mass measured by BMI.;Changes in body fat measured by DEXA.;Changes in body fat measured by abdominal CT.;Changes in body fat mass measured by bioimpedence
- Secondary Outcome Measures
Name Time Method Comparison of changes in waist circumference at fasting;Comparing total cholesterol changes comparing insulin changes;Compare total cholesterol changes;Compare total cholesterol changes;Compare HDL-C changes;Compare Apo B-100 Changes;Compare glucose changes;Comparing insulin changes;insulin??? ??