A prospective study for evaluating the validity and stability of body fat reduction when eating dandelion kimchi-derived lactobacillus in overweight or obese persons.
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007142
- Lead Sponsor
- PHARMSVILLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Those aged 19 or older and those aged 65 or younger;
2) Those with a body mass index greater than 25 kg/m2 and less than 32 kg/m2 in Visit 1 and Visit 2
3) A person who agrees to participate in this human application test and prepares a written agreement before the human application test begins.
1) Persons currently being treated for severe cardiovascular, immune system, respiratory system, mediastinometer, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious diseases, and malignant tumors.
2) A person who administers birth control pills and female hormones within one month (30 days) based on visit 1
3) Drugs that affect weight within 2 weeks of visit 1{obesity drugs (eating inhibitors, liposuction inhibitors, GLP-1 receptors, etc.), psychiatric drugs such as depression and schizophrenia, beta blockers, diuretics, steroids}, health functional foods/supplements and weight control preparations for weight control purposes
4) A person who has been administered antibiotics within two weeks as of Visit 1;
5) A person who has consumed probiotics and lactobacillus products continuously (at least four times a week) within two weeks based on visit 1
6) A person who has been administered herbal medicine for weight control within three months as of Visit 1;
7) Patients with unadjusted high blood pressure (160mmHg or higher in the contractor or 100mmHg or higher in the relaxer, and the standard of measurement after stabilizing for 10 minutes for human application test subjects)
8) Diabetes patients with more than 126 mg/dL of empty blood sugar or anti-diabetic drugs (such as oral blood sugar dropers, insulin, etc.)
9) TSH below 0.1 µIU/mL or above 10 µIU/mL
10) A person whose creatine is more than twice the normal upper limit of the institution;
11) A person whose AST(GOT) or ALT(GPT) is more than three times the normal upper limit of the institution;
12) A person who has a severe gastrointestinal disorder and has a problem in eating food for human application testing;
13) Alcohol use ? People with induced disorders and central neurological disorders
14) A person who is deemed unable to exercise due to musculoskeletal disorders;
15) A person who has changed his/her weight by at least 10% within three months as of Visit 1;
16) Persons who have participated in a commercial obesity program within three months as of Visit 1;
17) Those who have participated in other interventional clinical trials (including human application trials) within one month (30 days) as of Visit 1 or plan to participate in other interventional clinical trials (including human application trials) after the commencement of this human application test.
18) A person who is pregnant or has a pregnancy plan during the lactating women's or human application test period;
19) A person who is sensitive to or allergic to food ingredients for this human application test;
20) A person who determines that the tester is inappropriate for other reasons;
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fat mass
- Secondary Outcome Measures
Name Time Method Weight;Waist circumference, hip circumference, waist/hip circumference ratio;Body Mass Index;Fat free mass(Result of DEXA);Internal Fat Area, Subcutaneous Fat Area, Total Abdominal Fat Area, Internal/Subcutaneous Fat Area Ratio;Total Cholesterol , HDL Cholesterol, LDL Cholesterol, Triglyceride;hsCRP;High sensitivity C-reactive protein; Adiponectin , Leptin