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.

Semyung University0 sites150 target enrollmentTBD

ConditionsEndocrine, nutritional and metabolic diseases

Overview

Phase: 未知
Intervention: Not specified
Conditions: Endocrine, nutritional and metabolic diseases
Sponsor: Semyung University
Enrollment: 150
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional Study

Sex

All

Investigators

Sponsor

Semyung University

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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