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Completed

NCT Number: NCT01414465

Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)

Campinas, São Paulo, 13083-878, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orlistat

Drug

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

Primary outcomes

  1. Orlistat induced modulation on the Fatty Acid composition in Obese Females

    Time frame: 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 outcomes

  1. Orlistat induced modulation on the Fatty Acid composition in Obese Females

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Germed Pharma

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 11, 2011
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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