Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

This study has been completed.
Sponsor:
Collaborator:
Germed Pharma, Brazil
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01414465
First received: August 9, 2011
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Overweight
Drug: Orlistat

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Orlistat Induced Modulation on the Fatty Acid Composition of the Red Blood Cell Membrane and Plasma Phospholipids, Triglyceride and Cholesteryl Esters in Obese Females

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Orlistat induced modulation on the Fatty Acid composition in Obese Females [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Orlistat induced modulation on the Fatty Acid composition in Obese Females [ Time Frame: after 120 days Orlistat treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 17
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: low caloric diet
10 health obese women (BMI 30 to 40 kg/m2)
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
Experimental: Orlistat
10 obese women treated with Orlistat 120mg 3 times per day
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
Sham Comparator: lifestyle counseling
Women with BMI < 30 kg/m2, no taking drug in study
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

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.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414465

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, 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)
  More Information

No publications provided

Responsible Party: Bruno Geloneze, University of Campinas
ClinicalTrials.gov Identifier: NCT01414465     History of Changes
Other Study ID Numbers: LIMED0010
Study First Received: August 9, 2011
Last Updated: August 10, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
Fatty acids
orlistat
lipase
BMC (Body Mass Index) between 30 to 40 kg/m2
Women
18 to 45 years
Premenopausal stage

Additional relevant MeSH terms:
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 April 16, 2014