Efficacy and safety of FCCE on reducing body weight and body fat in overweight or obesity subjects; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0004991
• Lead Sponsor: SK bioland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Adult male and female between 20-65 years
2) BMI=25kg/m^2 and <30kg/m^2 for Visit1
3) Subject who voluntarily agrees to participate and sign in informed consent form

Exclusion Criteria

1) Subject with severe cerebrovascular disease (infarct, hemorrage), cardiac disease (angina, myocardiac infarct, heart failure, arrhythmias that require treatment) within recent 6 months. (If that patient's clinical status is stable, they can participate in the clinical trial according to investigator)
2) Patients with uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 100 mmHg, after 10 minutes of test subjects)
3) Subjects who fasting blood glucose = 126 mg/dL or random blood glucose= 200 mg/dL or diabetic patients use of hypoglycemic agent or insulin
4) Subject who TSH = 0.1 µU/ml or = 10 µU/ml
5) Subject who eGFR < 60 mL/min/1.73?
6) Subject who more than 3times the upper limit of normal AST(GOT) or ALT(GPT) of clinical trial institution
7) Subject with severe gastrointestinal disorders that have a problem with taking test material
8) Subject who was taking drugs that affect body weight within the past month (including absorption inhibitors and appetite suppressants, health functional foods / supplements related to obesity improvement, psychiatric drugs such as depression, beta blockers, diuretics, birth control pills, steroids)
9) Subject who participated in the commercial obesity program within the last 3 months
10) Subject who have participated or planned to participate in other clinical trials within the past month
11) Subject who are admitted to hospital, medication or rehabilitation due to alcohol use disorder ? related disorder, heart disease, central nervous disorder, etc. through medical history
12) Subject who are judged to be unable to exercise due to musculoskeletal disorders
13) Subject who is pregnant or is lactating or has a pregnancy plan during the period of the clinical trial
14) Subject who the opinion investigator make a judgment to be unsuitable for any other reason

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Body Fat by DEXA(Dual-energy X-ray absorptiometry)

Secondary Outcome Measures

Name	Time	Method
weight;Waist Circumference, Hip Circumferenc, Waist to Hip Ratio;Body Mass Index(BMI);Fat mass, Lean Mass by DEXA(Dual-energy X-ray absorptiometry);Visceral Fat Area, Subcutaneous Fat Area, Taoal Fat Area,Visceral fat / Subcutanesou Fat Ratio by CT;Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride;Adiponectin, hs-CRP, Leptin;treatment-emergent adverse events(TEAEs);clinical laboratory test(hematologic/chemistry examination, Urinalysis);Vital Sign(pulsus, arteriotony)