Effects of multiple probiotics administration on obesity and obesity related metabolic indicators: a randomized, double-blind, placebo-controlled trial
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002292
- Lead Sponsor
- Dongguk University Ilsan Oriental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1. BMI (body mass index) of over 25kg/m2, men and women aged between 20-60 years
2. Participants who voluntarily decided to participate in this human clinical study and those who agreed to it.
3. Participants who are reliable and willing to cooperate with this study.
1. patients who have lost or gain more than 10% of body weight within 3 months
2. severe liver or renal dysfunction(ALT(Alanine Aminotransferase), AST(Aspartate Aminotransferase) = 2.5 fold upper limit of normal) (Cr > 2.0mg/dl)
3. patients with any condition that can affect weight gain such as hypothyroidism, cushing syndrome
4. heart disease(heart failure, angina pectoris, myocardial infarction)
5. cancer or lung disease
6. patients who are diagnosed with cholelithiasis
7. Narrow angle glaucoma
8. past history of stroke, transient ischemic heart disease
9. Patients who have psychiatric disorder such as delirium, confusion or those who have psychiatric diseases that may affect the performance and evaluation of human clinical study.
10. patients who underwent surgeries for weight reduction(gastroplastia)
11. eating disorder such as anorexia nervosa and bulimia nervosa
12. patients who have taken anorexiants, relievers(without prescription), oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or any other medication within 3 months that can affect absorption, metabolism, excretion which can affect on weight.
13. who are on narcotics and neuropsychological drugs for weight reduction
14. patients who underwent anatomical change such as incision which makes it difficult to conduct physical measurements
15. pregnant women, women planning a pregnancy and those who receive hormone or SSRI (Selective Serotonin Reuptake Inhibitors) medication
16. patients who had received antiboitics or probiotics within 1 month
17. patients who have taken other medications provided by clinical trial within a month
18. patients who have given up on smoking within past 3 months but who have irregular smoking habit
19. In addition, based on the researcher's evaluation, participants who is not appropriate for participating in this human clinical study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference of body fat area in horizontal 4-5th lumbar CT images (total fat, internal fat, internal fat/total fat ratio);body weight;waist circumference; hip circumference;body mass index;fat mass;Body fat percentage
- Secondary Outcome Measures
Name Time Method fasting blood sugar (FBS);triglyceride (TG);total cholesterol ;HDL cholesterol ;AST, ALT;insulin;sBP, dBP;difference of intestinal microbiota