A randomized, double-blind, placebo comparative clinical trial to evaluate the functionality and safety of KPE01 and KPE02 for body fat reduction in overweight or obese adults.
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007879
- Lead Sponsor
- Semyung University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 150
1) Men and women between the ages of 19 and 60
2) Subjects with a body mass index (BMI) of 25 kg/m2 or more and less than 30 kg/m2
3) Subjects who consented to participate in this study and voluntarily signed a written consent form
1) Subjects with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumor within the last 6 months (however, cerebrovascular disease, heart disease) Subjects who have a medical history but are clinically stable may participate in the trial at the discretion of the investigator.)
2) Drugs that affect body weight (fat absorption inhibitors and appetite suppressants, health food/supplements related to obesity, psychiatric drugs such as depression, beta blockers, diuretics, contraceptives, steroids, female hormones) within the last 1 month subject who is taking
3) Obese or overweight subjects due to endocrine diseases such as hypothyroidism and Cushing's syndrome
4) Subjects who are continuously receiving treatment or taking medications for gastrointestinal disorders (gastric ulcer, chronic digestive disorder, irritable bowel syndrome, etc.)
5) Subjects with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol and other drug abuse
6) Subjects judged to be unable to exercise due to musculoskeletal disorders
7) Fasting blood sugar of 126 mg/dl or more, random blood sugar of 200 mg/dl or more, or diabetic patients taking oral hypoglycemic agents or insulin
8) Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg, measured after subject resting for 10 minutes)
9) Subjects whose AST(GOT) or ALT(GPT) is 2.5 times or more of the laboratory's upper limit of normal
10) Subjects with more than twice the upper limit of normal creatinine testing institute
11) Subjects who have lost 5% or more of weight within the last 3 months
12) Subjects who have participated in a commercial obesity program within the last 3 months
13) Subjects for whom 6 months have not elapsed since participating in the same trial
14) Subjects who are pregnant, lactating, or planning to become pregnant during the human application test period
15) Subjects who have an allergic reaction to food for human application testing
16) Subjects who are judged to be inappropriate as a researcher for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in body fat mass (g) and body fat percentage (%) using DEXA after 12 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method Change of lean mass (g) using DEXA after 12 weeks compared to baseline;Changes in body fat mass (g), body fat percentage (%) and lean mass (g) by area (Arms, Legs, Trunk, Android, Gynoid) using DEXA after 12 weeks from baseline;Changes in total fat area, subcutaneous fat area, visceral fat area, and visceral fat area/subcutaneous fat area ratio (VSR) measured by abdominal CT after 12 weeks from baseline;Changes in body weight after 4 weeks, 8 weeks, and 12 weeks compared to baseline;Changes in body mass index after 4 weeks, 8 weeks, and 12 weeks from baseline;Changes in waist circumference, hip circumference, waist circumference/hip circumference ratio after 4 weeks, 8 weeks, and 12 weeks from baseline;Changes in blood lipid concentrations (Total Cholesterol, LDL-Cholesterol, Triglyceride, HDL-Cholesterol) after 12 weeks from baseline;Changes in Leptin and Adiponectin after 12 weeks from baseline