Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

University of Campinas, Brazil

Status: Completed

Conditions: Overweight

Treatments: Drug: Orlistat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01414465

LIMED0010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

17 participants in 3 patient groups

low caloric diet

No Intervention group

Description:

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

Treatment:

Drug: Orlistat

Orlistat

Experimental group

Description:

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

Treatment:

Drug: Orlistat

lifestyle counseling

Sham Comparator group

Description:

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

Treatment:

Drug: Orlistat