None listed
Conditions
Interventions
Drug : participants agreed to clinical trial consent was assigned to either probiotics group or placebo group. participants are to administer either probiotics capsule 500mg or placebo capsule 500mg,
Sponsors
Dongguk University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: participants recruited via advertisement 1)women aged between 19-65 years 2)BMI of over 25kg/m2, waist circumference of over 85cm 3)participants who were explained about protocol and those who agreed to it.
Exclusion criteria
Exclusion criteria: 1)women with any condition that can affect weight gain such as hypothyroidism, cushing syndrome 2)heart disease(heart failure, angina pectoris, myocardial infarction) 3)uncontrolled blood pressure(SBP > 145 mmHg or DBP> 95 mmHg) 4)cancer or lung disease 5)women who are diagnosed with cholelithiasis 6)severe renal dysfunction (Cr > 2.0mg/dl) 7)liver dysfunction(ALT, AST = 2.5 fold upper limit of normal) 8)non-insulin dependent diabetes mellitus with FBS >140 mg/dL 9)Narrow angle glaucoma 10)neuropsychiatric diseases(schizophrenia, epilepsy, alcoholism, drug addiction, anorexia nervosa, hyperphagia) 11)past history of stroke, transient ischemic heart disease 12)eating disorder such as anorexia nervosa and bulimia nervosa 13)women 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. 14)women who have taken ß-blocker or diuretic as hypertension treatment within 3 months 15)who are on narcotics and neuropsychological drugs for weight reduction 16)other forbidden treatments(insulin, hypogycemic agents, antidepressants, anti serotonin reuptake inhibitor, sodium pentobarbital, antipsychotics, drugs concerned with misuse) 17)women who underwent anatomical change such as incision which makes it difficult to conduct physical measurements 18)women who underwent surgeries for weiight reduction(gastroplastia) 19)women who are judged to be unacceptable for candidate by person in charge of clinical trial 20)pregnant women, breast feeder, women planning a pregnancy and those who do not agree to use adequate contraception such as oral contraceptives, hormone transplant, IUD, spermicide, condom, celibacy. 21)women who have taken other medications provided by clinical trial within a month 22)wome who have lost more than 10% of body weight within 6 months 23)women who have given up on smoking within past 3 months but who have irregular smoking habit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ratio of obese women showing more than 3% of weight reduction compared with baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| value of weight reduction ;blood lipid profile;waist circumference;blood pressure;glucose level;intestinal permeability test;number of intestinal microbiota;endotoxin level;Korean Version of Obesity-related Quality of Life Scale | — |
Countries
Korea, Republic of
Contacts
Public ContactSin Lee
Dongguk University Ilsan Hospital
Outcome results
None listed