Study of Fat Malabsorption by Lipiblock Versus Xenical

This study has been completed.
Sponsor:
Collaborator:
Germed Pharma, Brazil
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01170806
First received: May 18, 2010
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Obesity
Drug: Orlistat

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Study of Pharmacodynamic Equivalence of Two Commercial Formulations of Orlistat (Lipiblock vs Xenical) on Intestinal Lipases Inhibition

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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:
  • Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition [ Time Frame: after 7 days Orlistat treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 20
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Orlistat
  • 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:
  • Orlistat
  • Xenical
  • Lipiblock
  • Tetrahydrolipstatin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170806

Locations
Brazil
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)
Campinas, Sao Paulo, Brazil, 13083-878
Sponsors and Collaborators
University of Campinas, Brazil
Germed Pharma, Brazil
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)
  More Information

No publications provided

Responsible Party: Bruno Geloneze, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01170806     History of Changes
Other Study ID Numbers: LIMED0008
Study First Received: May 18, 2010
Last Updated: January 28, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
Intestinal lipase
Orlistat
fecal fat
obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014