Clinical trial NCT01414465: Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Fatty acids
orlistat
lipase
BMC (Body Mass Index) between 30 to 40 kg/m2
Women
18 to 45 years
Premenopausal stage
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Germed Pharma
First posted: 2011-08-11
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Orlistat induced modulation on the Fatty Acid composition in Obese Females
timeFrame: baseline
Secondary outcomes:
measure: Orlistat induced modulation on the Fatty Acid composition in Obese Females
timeFrame: after 120 days Orlistat treatment
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)
state: Sao Paulo
Study officials:
affiliation: University of Campinas (UNICAMP)
name: Bruno Geloneze, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas (UNICAMP)
name: Sabrina Nagassaki, Dr
role: STUDY_CHAIR
affiliation: University of Campinas (UNICAMP)
name: Anita J Marsaioli, Dr
role: STUDY_CHAIR
affiliation: University of Campinas (UNICAMP)
name: Thiago Inacio B Lopes
role: STUDY_CHAIR
References: