Trial | NCT01414465  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    orlistat ...

  • Study Participants

    17
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.
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 Started
Oct 31
2009
Primary Completion
Mar 31
2010
Study Completion
Jun 30
2011
Last Update
Aug 11
2011
Estimate

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

low caloric diet No Intervention

10 health obese women (BMI 30 to 40 kg/m2)

Orlistat Experimental

10 obese women treated with Orlistat 120mg 3 times per day

lifestyle counseling Sham Comparator

Women with BMI < 30 kg/m2, no taking drug in study

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
No Results Posted