Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

Orlistat Induced Modulation on the Fatty Acid Composition of the Red Blood Cell Membrane and Plasma Phospholipids, Triglyceride and Cholesteryl Esters in Obese Females

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13083-878
      • LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orlistat induced modulation on the Fatty Acid composition in Obese Females	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orlistat induced modulation on the Fatty Acid composition in Obese Females	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.	after 120 days Orlistat treatment

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Collaborators: Germed Pharma
• 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)

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (ESTIMATE): August 11, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2011
• Last Update Submitted That Met QC Criteria: August 10, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Women; orlistat; Fatty acids; lipase; BMC (Body Mass Index) between 30 to 40 kg/m2; 18 to 45 years; Premenopausal stage
• Additional Relevant MeSH Terms: Body Weight; Overweight; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Anti-Obesity Agents; Orlistat
• Other Study ID Numbers: LIMED0010