Effect of Lythrum salicaria extract on body fat reduction; a randomized, double-blinded, placebo-controlled clinical trial
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008060
- Lead Sponsor
- Sangji University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1. A person who consented to participate in this study and voluntarily signed a written consent form
2. Adult men and women between the ages of 19 and 75
3. A person with a body mass index(BMI) of 23 to 30 kg/m2
1. Subjects with severe cerebrovascular disease(cerebral infarction, cerebral hemorrhage, etc.), heart disease(angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumor within the last 6 months
2. Patients with uncontrolled hypertension (blood pressure of 160/100mmHg or higher, measurement standard after subject resting for 10 minutes)
3. Diabetic patients with poor blood sugar control (fasting blood sugar of 160mg/dl or higher)
4. Those who are being treated for hypothyroidism or hyperthyroidism
5. A person whose creatinine measurement value is more than twice the upper limit of normal of the research institution
6. A person whose AST (GOT) or ALT (GPT) measurement value is more than 3 times the upper limit of normal of the research institution
7. Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion (lactose intolerance)
8. A person who has been taking drugs that affect weight within the past month
9. Those who have participated in a commercial obesity program within the last 3 months
10. Those who have participated or plan to participate in other clinical trials within the last month
11. Alcohol Abuse
12. Non-smoking within 3 months
13. Those who are pregnant/lactating or plan to become pregnant during the human application test period
14. A person who has an allergic reaction to component foods
15. A person who is judged to be unsuitable by the tester for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method body fat mass(kg) through DEXA(Dual Energy X-Ray Absorptiometry)
- Secondary Outcome Measures
Name Time Method Body Mass Index(BMI);body weight(BWT);Waist to Hip Ratio(WHR);Body fat percentage (%), lean body mass (kg) through DEXA;Lipids(total cholesterol, Tryglyceride, HDL-C, calculated LDL-C);Free Fatty Acid(FFA);hs-CRP;Adiponectin;Leptin