Study of Fat Malabsorption by Lipiblock Versus Xenical

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Drug: Orlistat

• Registration Number: NCT01170806
• Lead Sponsor: University of Campinas, Brazil

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-28
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Orlistat (Lipiblock) treatment	Orlistat	Lipiblock is a new Orlistat formulation, produce by Germed Pharma, Brazil. Capsule 120mg
Orlistat (Xenical) treatment	Orlistat	Xenical is a innovator Orlistat formulation, produced by Roche

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP); 🇧🇷 Campinas, Sao Paulo, Brazil