NCT01170806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
Last Updated

January 31, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

May 18, 2010

Last Update Submit

January 28, 2011

Conditions

Obesity

Keywords

Intestinal lipaseOrlistatfecal fatobesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Secondary Outcomes (1)

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

    after 7 days Orlistat treatment

Study Arms (2)

Orlistat (Lipiblock) treatment

ACTIVE COMPARATOR

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

Drug: Orlistat

Orlistat (Xenical) treatment

ACTIVE COMPARATOR

Xenical is a innovator Orlistat formulation, produced by Roche

Drug: Orlistat

Interventions

OrlistatDRUG

Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy

Also known as: Xenical, Lipiblock, Tetrahydrolipstatin
Orlistat (Lipiblock) treatmentOrlistat (Xenical) treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obesity
  • BMC (Body Mass Index) between 30 to 40 kg/m2
  • Women
  • to 45 years
  • Premenopausal stage

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Campinas, São Paulo, 13083-878, Brazil

Location

MeSH Terms

Conditions

Obesity

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • Bruno Geloneze, MD PhD

    University of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2010

First Posted

July 27, 2010

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

January 31, 2011

Record last verified: 2011-01

Locations

BR(1)