Study of Fat Malabsorption by Lipiblock Versus Xenical

January 28, 2011 updated by: University of Campinas, Brazil

Study of Pharmacodynamic Equivalence of Two Commercial Formulations of Orlistat (Lipiblock vs Xenical) on Intestinal Lipases Inhibition

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13083-878
        • LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Orlistat (Lipiblock) treatment
Lipiblock is a new Orlistat formulation, produce by Germed Pharma, Brazil. Capsule 120mg
Drug: Orlistat
Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy
Other Names:
  • Xenical
  • Lipiblock
  • Tetrahydrolipstatin
Active Comparator: Orlistat (Xenical) treatment
Xenical is a innovator Orlistat formulation, produced by Roche
Drug: Orlistat
Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy
Other Names:
  • Xenical
  • Lipiblock
  • Tetrahydrolipstatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition
Time Frame: 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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition
Time Frame: 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.
after 7 days Orlistat treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Germed Pharma

Investigators

  • Principal Investigator: Bruno Geloneze, MD PhD, University of Campinas (UNICAMP)
  • Study Chair: Sabrina Nagassaki, PharmD PhD, University of Campinas (UNICAMP)
  • Study Chair: Christiane Stabe, MSc, University of Campinas (UNICAMP)
  • Study Chair: Daniela Tezoto, University of Campinas (UNICAMP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIMED0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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