Evaluation of the Efficacy and Safety of Kaempferia parviflora extract on Body Fat
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009398
- Lead Sponsor
- Dong-A University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) More than 20 years old
2) The body mass index (BMI) is 25 kg/m2 or more than 25 kg/m 2 or less than 30 kg/m 2
3) Before the human application experience of this human application test before the human application test begins, and in writing agreements
1) A person currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary systems, kidney and urinary systems, nervous system, psychiatric, infectious diseases, and malignancies (but can participate in the test at the discretion of the tester considering the subject's condition)
2) A person who has a history of surgery through general anesthesia within six months from the first visit ( Provided, That in the case of obesity surgery, within one year)
3) A person who has used subcutaneous injections (heparin, insulin) within one year from visit 1
4) Those who used the following drugs within one month (30 days) of visit - Obesity drugs (eating suppression, fat absorption inhibitors, GLP-1 receptor agonists, etc.) - Psychiatric drugs such as depression and schizophrenia - Beta blockers, diuretics, female hormones, male hormones, adrenal cortical hormones, thyroid hormones, immunosuppressants, proton pump inhibitors
5) Those who use the following health functional foods, etc. within three months of visit - Health functional foods that improve hyperlipidemia drugs, blood lipids and cholesterol {Omega 3 (maintained with EPA and DHA), ovarian harmonic maltodextrin, maintained with gamma-linolenic acid, lecithin, plant cholesterol, etc.} - Health functional foods/supplements for weight control purposes, herbal medicines, and weight control preparation foods
6) Uncontrolled hypertension patients (measured after systolic blood pressure of 140 mmHg or diastolic blood pressure of 90 mmHg or more, test subjects of 10 minutes of stability)
7) Diabetes patients with fasting blood sugar of 126 mg/dL or more or taking antidiabetic medications (such as oral hypoglycemic drugs)
8) Any person whose TSH is out of the normal range of the implementer
9) Those with eGFR less than 60 mL/min/1.73 m2
10) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the implementation engine
11) Alcohol drinkers exceeding the appropriate amount [male = 40 g/day, female = 20 g/day (WHO's daily alcohol intake standard)]
12) Excessive smokers (=20 cigarettes/day)
13) A person who is deemed unable to exercise due to musculoskeletal disorders
14) A person who has changed his/her weight by 10% or more or 5 kg or more within 3 months from visit 1
15) A person who participated in a commercial obesity program within three months from the first visit
16) A person who has given birth within 6 months as of visit 1, is pregnant, is nursing, or is planning to become pregnant during the self-application test period
17) A person who has a problem with the intake of food for human application tests due to severe gastrointestinal disorders
18) A person who is sensitive or allergic to food ingredients for this human application test
19) A person who has metal in the body due to surgery, etc
20) A person who has participated in other interventional clinical trials (including human application tests) within three months of the visit, or who plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
21) A person who finds the tester inappropriate due to other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mount of body fat through DEXA
- Secondary Outcome Measures
Name Time Method body weight;body mass index(BMI);thigh, arm, waist, hip circumference, waist/hip circumference;Body fat percentage and fat control through DEXA;visceral fat, subcutaneous fat, total abdominal fat area, visceral/subcutaneous fat area ratio through CT;blood lipid(Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride); a blood indicator(Free Fatty Acid, Ketone)