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Study of Fat Malabsorption by Lipiblock Versus Xenical

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Orlistat
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Intestinal lipase, Orlistat, fecal fat, obesity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Orlistat (Lipiblock) treatment

Orlistat (Xenical) treatment

Arm Description

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

Xenical is a innovator Orlistat formulation, produced by Roche

Outcomes

Primary Outcome Measures

Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition
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
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.

Full Information

First Posted
May 18, 2010
Last Updated
January 28, 2011
Sponsor
University of Campinas, Brazil
Collaborators
Germed Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01170806
Brief Title
Study of Fat Malabsorption by Lipiblock Versus Xenical
Official Title
Study of Pharmacodynamic Equivalence of Two Commercial Formulations of Orlistat (Lipiblock vs Xenical) on Intestinal Lipases Inhibition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Campinas, Brazil
Collaborators
Germed Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Intestinal lipase, Orlistat, fecal fat, obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orlistat (Lipiblock) treatment
Arm Type
Active Comparator
Arm Description
Lipiblock is a new Orlistat formulation, produce by Germed Pharma, Brazil. Capsule 120mg
Arm Title
Orlistat (Xenical) treatment
Arm Type
Active Comparator
Arm Description
Xenical is a innovator Orlistat formulation, produced by Roche
Intervention Type
Drug
Intervention Name(s)
Orlistat
Other Intervention Name(s)
Xenical, Lipiblock, Tetrahydrolipstatin
Intervention Description
Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy
Primary Outcome Measure Information:
Title
Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition
Description
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.
Time Frame
after 7 days Orlistat treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Geloneze, MD PhD
Organizational Affiliation
University of Campinas (UNICAMP)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sabrina Nagassaki, PharmD PhD
Organizational Affiliation
University of Campinas (UNICAMP)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christiane Stabe, MSc
Organizational Affiliation
University of Campinas (UNICAMP)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniela Tezoto
Organizational Affiliation
University of Campinas (UNICAMP)
Official's Role
Study Chair
Facility Information:
Facility Name
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-878
Country
Brazil

12. IPD Sharing Statement

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Study of Fat Malabsorption by Lipiblock Versus Xenical

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