None listed
Conditions
Interventions
Dietary Supplement : Experimental group : administration of probiotics 1 capsule(500mg) p.o. twice a day for total 12 weeks
Control group: administration of placebo 1 capsule (500mg) p.o. twice a day
Sponsors
Dongguk University Ilsan Oriental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| fasting blood sugar (FBS);triglyceride (TG);total cholesterol ;HDL cholesterol ;AST, ALT;insulin;sBP, dBP;difference of intestinal microbiota | — |
Countries
Korea, Republic of
Contacts
Public ContactHojun Kim
Dongguk University
Outcome results
None listed