Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Overweight |
Drug: Orlistat |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- Orlistat induced modulation on the Fatty Acid composition in Obese Females [ Time Frame: baseline ] [ Designated as safety issue: Yes ]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.
- Orlistat induced modulation on the Fatty Acid composition in Obese Females [ Time Frame: after 120 days Orlistat treatment ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 17 |
| Study Start Date: | October 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: low caloric diet
10 health obese women (BMI 30 to 40 kg/m2)
|
Drug: Orlistat
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
|
|
Experimental: Orlistat
10 obese women treated with Orlistat 120mg 3 times per day
|
Drug: Orlistat
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
|
|
Sham Comparator: lifestyle counseling
Women with BMI < 30 kg/m2, no taking drug in study
|
Drug: Orlistat
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
|
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Brazil | |
| LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP) | |
| Campinas, Sao Paulo, Brazil, 13083-878 | |
| Principal Investigator: | Bruno Geloneze, Dr | University of Campinas (UNICAMP) |
| Study Chair: | Sabrina Nagassaki, Dr | University of Campinas (UNICAMP) |
| Study Chair: | Anita J Marsaioli, Dr | University of Campinas (UNICAMP) |
| Study Chair: | Thiago Inacio B Lopes | University of Campinas (UNICAMP) |
More Information
No publications provided
| Responsible Party: | Bruno Geloneze, University of Campinas |
| ClinicalTrials.gov Identifier: | NCT01414465 History of Changes |
| Other Study ID Numbers: | LIMED0010 |
| Study First Received: | August 9, 2011 |
| Last Updated: | August 10, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Campinas, Brazil:
|
Fatty acids orlistat lipase BMC (Body Mass Index) between 30 to 40 kg/m2 |
Women 18 to 45 years Premenopausal stage |
Additional relevant MeSH terms:
|
Overweight Body Weight Signs and Symptoms Orlistat Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013