Obesity Visceral fat
Conditions
Interventions
Orlistat 180 mg/day for 8 weeks
D019440
Orlistat
Sponsors
Nakazato Masamitsu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Japanese men aged 35 to 59 years old with over 85 cm of waist circumference
Exclusion criteria
Exclusion criteria: The person corresponding to any of the following condition does not intend. 1)Secondary obesity 2)The person who had taken orlistat 3)The person whose obesity index is more than +70% or BMI is more than 35.0 4)The person whose waist circumference changed remarkably within pre-three months (90 days) at screening 5)The person who does not work on lifestyle improvement (exercise and dietary modification for the purpose of the weight loss) and eating habits including the overeating and overdrinking more than two months (60 days) before screening start 6)The person with abnoramal bowel movement that was evaluated by bowel movement frequency and the Bristol feces property scale during a screening period 7)The person who is positive by fecal occult-blood testing at the time of the screening start 8) The person who is treated obesity under the management of the medical doctor 9)The person who is treated diabetes, dyslipidemia, hyperuricemia, gout, or fatty liver under the management of the medical doctor 10)The person using the following drugs before a month of screening or a screening period Anti-obesity drug (mazindol, setilistat) Herbal medicine having anti-obesity Diabetes therapeutic drug Steroid medicine Various hormone medicine Psychotropic drug Benzodiazepine drugs Antiepileptic drug Antibiotic, cathartic medicine for intestinal disorders Nonsteroidal antiinflammatory drug (NSAIDs) Drug which may have an influence to enterobacterial flora (influence to gastric acid secretion such as proton pump inhibitors), bile acid secretion (ursodeoxycholic acid), a non-fixed form psychotropic drug 11)The person who began or stopped nasal CPAP therapy before 6 months (180 days) of screening or a screening period 12)The person who took following or during a screening period or within one month (30th) before screening start. In addition, the person who began to take following during a screening period or within one month (30 days) before screening start. Food considered to have action such as fat absorption restraint, decrease of the body fat, visceral fat, or waist circumference Food considered to have the action to the bowels including intestine conditioning activity (yogurt, lactic acid bacterium drink, cheese, natto, kimchi, amazake, nukazuke). However, the person who took it in as dietary habits continuously is excluded. Substitute meal (e.g. microdiet) for the purpose of the weight loss 13)The person who had done massage or beauty salon treatment, used an apparatus (e.g. six pads) or correction underwear 14)The person who had done the operation of fat cooling, ultrasonic wave, or electromagnetic wave for the purpose of the weight loss 15)The person who had done the operation including liposuction, a fat fusion laser, or the gastrointestinal tract 16)The person who has to use drugs or do the tratment those are provided by this program during a study period 17)The person who began or stopped smoking before 3 months (90 days) of screening or a screening period 18)The person who has the past history or has serious disease (heart, blood vessel, blood, respiratory system, liver, kidney, alimentary system, neurologic mental disease) 19)The person who is complicated with a coronary disease or a cerebro-vascular disease 20)The person who is complicated with endocrinopathy (hypothyroidism, cushing syndrome, etc.) 21)The person who is com
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of intestinal flora | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change of serum zonulin level 2. The change of the organic acid in feces (acetic acid, propionic acid, succinic acid, lactic acid, iso-butyric acid, iso-valeric acid, n-butyric acid, n-valeric acid, formic acid) 3. The change of visceral fat area 4. The change of waist circumference 5. The change of body weight 6. The change of various markers (des-acyl ghrelin, ghrelin, active GLP-1, insulin, leptin, active GIP, FGF21) 7. The change of percent of body fat, fat mass, skeletal muscle mass, BMI, the waist hip ratio, fluid volume in the cell, fluid volume out of the cell, protein mass, the amount of mineral | — |
Contacts
Public ContactHiroaki Ueno
University of Miyazaki
Outcome results
None listed