The effects of orlistat to enterobacterial flora and so on

JRCT ID: jRCTs071190050

Registered date:09/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 16/06/2020
• Target sample size: 14
• Study type: Interventional
• Intervention(s): Orlistat 180 mg/day for 8 weeks

Outcome(s)

• Primary Outcome: Change of intestinal flora

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 35age old
• Age maximum: <= 59age old
• Gender: Male
• Include criteria: Japanese men aged 35 to 59 years old with over 85 cm of waist circumference

Exclude 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
<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

• Primary Sponsor: Nakazato Masamitsu
• Source(s) of Monetary Support: Taisho Pharmaceutical Co. Ltd.