weight, blood lipid metabolism, intestinal permeability and intestinal microorganism in obese Korean wome
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000386
- Lead Sponsor
- Dongguk University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 40
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ratio of obese women showing more than 3% of weight reduction compared with baseline
- Secondary Outcome Measures
Name Time Method 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