KCT0007117Active, not recruiting未知
A 12 week, Double-blind, Randomized, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of L. curvatus HY7601 and L. plantarum KY1032 on Reducing body weight and body fat on Overweight or Obesity subjects
Vievis NAMUH Hospital0 sites72 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 72
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20?(Year) to 65?(Year) (—)
- Sex
- All
Inclusion Criteria
- •1) Subjects who are adult men and women between 20~65 years of age
- •2) BMI of visit 1,2 is placed on 23 kg/m2~35 kg/m2
- •3) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
Exclusion Criteria
- •1) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization)
- •2) Diabetic patients taking fasting blood glucose levels greater than 126 mg / dl, randomized blood glucose levels greater than 200 mg / dl, or taking oral hypoglycemic agents or insulin
- •3) subject currently being treated for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychiatric, infectious diseases and malignancies.
- •4) subject who has clinically clear risk factors for gastrointestinal bleeding, or those who are judged by the investigator to have other bleeding tendencies
- •5) subject who has been diagnosed with or treated for cancer within 5 years of visit 1
- •6) Drugs that affect body weight Within 1 month based on visit 1(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, Who are taking medicines to treat hyperlipidemia
- •7) Subject who has administered antibiotics or immunosuppressants within 2 weeks of visit 1
- •8) Subject who has consumed probiotics and lactobacillus products continuously (4 or more times a week) within 2 weeks of visit 1
- •9) Subject who has had a weight change of 10% or more within the last 3 months
- •10) Subject who has participated in a commercial obesity program in the past 3 months
- •11)Patient with thyroid dysfunction who is TSH = 0.1 µU/ml or = 10 µU/ml
- •12) Patient with renal dysfunction who is more than 2 times the upper limit of normal Creatinine of clinical trial institution
- •13) Patient with hepatic dysfunction who is more than 3 times the upper limit of normal AST(GOT) or ALT(GPT) of clinical trial institution
- •14) Patient with mental disorders such as depression, schizophrenia, alcoholism, drug addiction, etc.
- •15) Subject who judged unable to exercise due to severe musculoskeletal disorders
- •16) Anyone who is pregnant or has a pregnancy plan for the duration of the test
- •17) Anyone who has participated or planned to participate in other clinical trials within the past one month
- •18) Subject who is sensitive or has an allergic reaction to food for human application testing
- •19) Anyone who is found to be inadequate by the tester for other reasons
Investigators
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