NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071190050

Registered date:09/03/2020

The effects of orlistat to enterobacterial flora and so on

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedObesity
Date of first enrollment16/06/2020
Target sample size14
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Orlistat 180 mg/day for 8 weeks

Outcome(s)

Primary OutcomeChange of intestinal flora
Secondary Outcome1. 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

Key inclusion & exclusion criteria

Age minimum>= 35age old
Age maximum<= 59age old
GenderMale
Include criteriaJapanese men aged 35 to 59 years old with over 85 cm of waist circumference
Exclude criteriaThe 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 <1> Anti-obesity drug (mazindol, setilistat) <2> Herbal medicine having anti-obesity <3> Diabetes therapeutic drug <4> Steroid medicine <5> Various hormone medicine <6> Psychotropic drug <7> Benzodiazepine drugs <8> Antiepileptic drug <9> Antibiotic, cathartic medicine for intestinal disorders <10> Nonsteroidal antiinflammatory drug (NSAIDs) <11> 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 <1> or <3> during a screening period or within one month (30th) before screening start. In addition, the person who began to take following <2> during a screening period or within one month (30 days) before screening start. <1> Food considered to have action such as fat absorption restraint, decrease of the body fat, visceral fat, or waist circumference <2> 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. <3> 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 complicated with a gastric ulcer, a duodenal ulcer 22)The person who is complicated with malabsorption syndrome 23)The person who is complicated or has the past history of pancreas enzyme deficiency, pancreatitis 24) The person who has undergone organ transplantation 25)The person who is complicated or has the past history of cholestasis, cholecystitis, gallstone, renal calculus, hyperoxaluria 26)The person who is complicated or has the past history of anorexia, bulimia 27)The person who is complicated or has the past history of abuse of the laxative 28)Person with the past history of drug hypersensitivity 29)Person of alcohol or the drug dependency 30)Person without a custom to usually take in food three meals (breakfast, lunch, dinner) in a day regularly 31)Person with extremely irregular lifestyle 32)The person who does not have ability for voluntary agreement 33)The person who has participated in other clinical trials before a months (30 days) of screening or a screening period 34)The person who stayed abroad within most recent one month, or will go abroad during a study period 35)In addition, the person who judged a study responsibility (allotment) doctor to be inadequate as an object of this study

Related Information

Contact

Public contact
Name Hiroaki Ueno
Address Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan Miyazaki Japan 889-1692
Telephone +81-985-85-2965
E-mail intron@med.miyazaki-u.ac.jp
Affiliation University of Miyazaki
Scientific contact
Name Masamitsu Nakazato
Address Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan Miyazaki Japan 889-1692
Telephone +81-985-85-2965
E-mail nakazato@med.miyazaki-u.ac.jp
Affiliation Faculty of Medicine, University of Miyazaki Hospital