Study of Fat Malabsorption by Lipiblock Versus Xenical

University of Campinas, Brazil

Status: Completed

Conditions: Obesity

Treatments: Drug: Orlistat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01170806

LIMED0008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Orlistat (Lipiblock) treatment

Active Comparator group

Description:

Lipiblock is a new Orlistat formulation, produce by Germed Pharma, Brazil. Capsule 120mg

Treatment:

Drug: Orlistat

Orlistat (Xenical) treatment

Active Comparator group

Description:

Xenical is a innovator Orlistat formulation, produced by Roche

Treatment:

Drug: Orlistat