Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Drug: Orlistat

• Registration Number: NCT01414465
• Lead Sponsor: University of Campinas, Brazil

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-03
• Study Completion: 2011-06
• Status Verified: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Last Update Submitted: 2011-08-10
• Study First Posted: 2011-08-11
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• Obesity BMC (Body Mass Index) between 30 to 40 kg/m2 Women 18 to 45 years Premenopausal stage

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low caloric diet	Orlistat	10 health obese women (BMI 30 to 40 kg/m2)
Orlistat	Orlistat	10 obese women treated with Orlistat 120mg 3 times per day
lifestyle counseling	Orlistat	Women with BMI \< 30 kg/m2, no taking drug in study

Primary Outcome Measures

Name	Time	Method
Orlistat induced modulation on the Fatty Acid composition in Obese Females	baseline	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

Name	Time	Method
Orlistat induced modulation on the Fatty Acid composition in Obese Females	after 120 days Orlistat treatment	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.

Trial Locations

Locations (1)

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP); 🇧🇷 Campinas, Sao Paulo, Brazil