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Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

Information source: University of Campinas, Brazil
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overweight

Intervention: Orlistat (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Campinas, Brazil

Official(s) and/or principal investigator(s):
Bruno Geloneze, Dr, Principal Investigator, Affiliation: University of Campinas (UNICAMP)
Sabrina Nagassaki, Dr, Study Chair, Affiliation: University of Campinas (UNICAMP)
Anita J Marsaioli, Dr, Study Chair, Affiliation: University of Campinas (UNICAMP)
Thiago Inacio B Lopes, Study Chair, Affiliation: University of Campinas (UNICAMP)

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Orlistat induced modulation on the Fatty Acid composition in Obese Females

Secondary outcome: Orlistat induced modulation on the Fatty Acid composition in Obese Females

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

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

Starting date: October 2009
Last updated: August 10, 2011

Page last updated: August 23, 2015

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