Obesity
Conditions
Keywords
Intestinal lipase, Orlistat, fecal fat, obesity
Brief summary
Obesity is a chronic condition with fat-rich diets playing a major role in its etiology. Pharmacological therapy has been proposed for weight loss and maintenance. This study aims to study the intestinal lipase blockade by partial inhibition of fat absorption after treatment with two commercials formulations of Orlistat.
Detailed description
The overweight and obesity epidemic affects approximately 1.6 millions of people worldwide. Obesity is a chronic condition, associated with premature death, co-morbidities, risk factors for main cardiac disease, stigmatization and significant economic costs. The causes of obesity are complex and include the interplay of environmental, social, economic and genetic factors. Besides fat-rich diets also play a significant role in the etiology of obesity. Correct diet orientation associated with physical exercise usually did not lead to expected result in weight loss and maintenance. Pharmacological therapy has been proposed as an adjunct to achieve the ideal weight. Orlistat acts in reduction of lipids absorption by inhibition of gastric and pancreatic lipases in gastrointestinal tract leading to sustained weight loss. This is a double blind study, randomized, of 2 weeks. The aim of this study was evaluate the intestinal lipase blockade by decrease of fat absorption of fecal fat after treatment with two commercials formulations of Orlistat in obese patients.
Interventions
DRUGOrlistat
Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy
Sponsors
Germed Pharma
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Obesity * BMC (Body Mass Index) between 30 to 40 kg/m2 * Women * 18 to 45 years * Premenopausal stage
Exclusion criteria
* Relevant diseases (diabetes, cardiovascular, gastrointestinal, renal and hepatic diseases, endocrine disorders, hemoglobinopatHy or neoplasm in the last three years) * Chemical or natural laxatives * Weight variation greater than 5% in the preceding 3 months * Surgery for weight reduction * Drugs to obesity control and/or oral corticosteroids anti-inflammatory in the last three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition | baseline | This study aim to investigate differences in fat absorption inhibition after 7 days treatment with Lipiblock and Xenical (two commercial capsules of Orlistat). Therefore, total fecal fat and fecal fat percentage wil be analysed, comparing these data before and after treatment with Lipiblock and Xeical. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition | after 7 days Orlistat treatment | This study aim to investigate differences in fat absorption inhibition after 7 days treatment with Lipiblock and Xenical (two commercial capsules of Orlistat). Therefore, total fecal fat and fecal fat percentage wil be analysed, comparing these data before and after treatment with Lipiblock and Xenical. |
Countries
Brazil
Outcome results
None listed