Clinical Trial for the Evaluation of the Efficacy and Safety of WHS on Reducing Body Weight and Body Fat of Overweight or Obesity subjects
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005594
- Lead Sponsor
- H Plus Yangji Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1) Subjects between 19 ~65 years of age
2) BMI of visit 1,2 is placed on 25 kg/m2 ~ 32 kg/m2
3) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
1) Subject with severe cerebrovascular disease (infarct, hemorrage), cardiac disease (angina, myocardiac infarct, heart failure, arrhythmias that require treatment). (If that patient's clinical status is stable, they can participate in the clinical trial according to investigator)
2) Subject who was taking drugs that affect body weight within the past month{drugs for obesity(including appetite suppressants, liposuction inhibitor, GLP-1 receptor agonists), psychiatric drugs such as depression,
beta blockers, diuretics, birth control pills, steroids)}, health functional foods / supplements related to obesity improvement
3) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization)
4) Subject who fasting blood glucose = 126 mg/dL or diabetic patients use of hypoglycemic agent or insulin
5) Subject who TSH = 0.1 µU/ml or = 10 µU/ml
6) Subject who more than 2 times the upper limit of normal Creatinine of clinical trial institution
7) Subject who more than 3 times the upper limit of normal AST(GOT) or ALT(GPT) of clinical trial institution
8) Subject with severe gastrointestinal disturbances who are suffering from ingestion of test food
9) Subject with Alcohol disorders, disorder of central nervous system
10) Subject who are determined to be unable to exercise due to musculoskeletal disorders
11) Subject who have had a weight change of 10% or more within the last 3 months
12) Subject who have participated in a commercial obesity program in the past 3 months
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fat mass 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);Percent Body Fat, 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;hs-CRP;Adiponectin, Leptin