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Trial record 3 of 69 for:    ORLISTAT

Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

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ClinicalTrials.gov Identifier: NCT01414465
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Sponsor:
Collaborator:
Germed Pharma
Information provided by:
University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE August 9, 2011
First Posted Date  ICMJE August 11, 2011
Last Update Posted Date August 11, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2011)
Orlistat induced modulation on the Fatty Acid composition in Obese Females [ Time Frame: baseline ]
This study aims to present alteration of FA composition in RBCM and phospholipids, triglycerides and cholesteryl esters from plasma of health obese female volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2011)
Orlistat induced modulation on the Fatty Acid composition in Obese Females [ Time Frame: after 120 days Orlistat treatment ]
This study aims to present alteration of FA composition in RBCM and phospholipids, triglycerides and cholesteryl esters from plasma of health obese female volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females
Official Title  ICMJE Orlistat Induced Modulation on the Fatty Acid Composition of the Red Blood Cell Membrane and Plasma Phospholipids, Triglyceride and Cholesteryl Esters in Obese Females
Brief Summary Orlistat is a popular drug approved for long-term use which produces weight loss by inhibiting triglycerides, main components of fats in the diet and reducing dietary fat absorption by up to 30%. The effect of this drug on human blood fatty acid profile has not been described yet. The FA composition of RBCs, plasma and platelets can be used to monitor of many pathological processes. This study presents alteration of FA composition in RBCM and phospholipids, triglycerides and cholesteryl esters from plasma of health obese female volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.
Detailed Description

Obesity treatment requires lifestyle changes such as diet, exercise, and behavioral therapy. Orlistat is a popular drug approved for long-term use which produces weight loss by inhibiting triglycerides, main components of fats in the diet, from binding to the lipase enzyme active sites thus halting their subsequent breakdown into monoglycerides and free fatty acids necessary for fat digestion, reducing dietary fat absorption by up to 30%. The effect of this drug on human blood fatty acid profile has not been described yet.

The FA profile is typical of each lipid and tissue, however, alterations in diets, pathological processes, drugs intervention, cigarettes and alcohol consumption can alter the FA profile. The FA composition of RBCs, plasma and platelets can be used to monitor these processes. This study presents alteration of FA composition in RBCM and phospholipids, triglycerides and cholesteryl esters from plasma of health obese female volunteers treated with nutritional orientation and orlistat (120 mg t.i.d) for 3 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overweight
Intervention  ICMJE Drug: Orlistat
Obese women were treated with orlistat 120mg 3 times a day for 4 months, compared with basal data and with normal weight women that didn´t receive orlistat
Study Arms  ICMJE
  • No Intervention: low caloric diet
    10 health obese women (BMI 30 to 40 kg/m2)
    Intervention: Drug: Orlistat
  • Experimental: Orlistat
    10 obese women treated with Orlistat 120mg 3 times per day
    Intervention: Drug: Orlistat
  • Sham Comparator: lifestyle counseling
    Women with BMI < 30 kg/m2, no taking drug in study
    Intervention: Drug: Orlistat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2011)
17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01414465
Other Study ID Numbers  ICMJE LIMED0010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruno Geloneze, University of Campinas
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Germed Pharma
Investigators  ICMJE
Principal Investigator: Bruno Geloneze, Dr University of Campinas (UNICAMP)
Study Chair: Sabrina Nagassaki, Dr University of Campinas (UNICAMP)
Study Chair: Anita J Marsaioli, Dr University of Campinas (UNICAMP)
Study Chair: Thiago Inacio B Lopes University of Campinas (UNICAMP)
PRS Account University of Campinas, Brazil
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP