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Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

Primary Purpose

Overweight

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Orlistat

About this trial

This is an interventional treatment trial for Overweight focused on measuring Fatty acids, orlistat, lipase, BMC (Body Mass Index) between 30 to 40 kg/m2, Women, 18 to 45 years, Premenopausal stage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Sham Comparator

Arm Label

low caloric diet

Orlistat

lifestyle counseling

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Orlistat induced modulation on the Fatty Acid composition in Obese Females

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

Orlistat induced modulation on the Fatty Acid composition in Obese Females

Full Information

NCT ID

NCT01414465

First Posted

August 9, 2011

Last Updated

August 10, 2011

Sponsor

University of Campinas, Brazil

Collaborators

Germed Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01414465

Brief Title

Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

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 Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Campinas, Brazil

Collaborators

Germed Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight

Keywords

Fatty acids, orlistat, lipase, BMC (Body Mass Index) between 30 to 40 kg/m2, Women, 18 to 45 years, Premenopausal stage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

low caloric diet

Arm Type

No Intervention

Arm Description

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

Arm Title

Orlistat

Arm Type

Experimental

Arm Description

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

Arm Title

lifestyle counseling

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Orlistat

Intervention Description

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 Outcome Measure Information:

Title

Orlistat induced modulation on the Fatty Acid composition in Obese Females

Description

Time Frame

baseline

Secondary Outcome Measure Information:

Title

Orlistat induced modulation on the Fatty Acid composition in Obese Females

Description

Time Frame

after 120 days Orlistat treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno Geloneze, Dr

Organizational Affiliation

University of Campinas (UNICAMP)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sabrina Nagassaki, Dr

Organizational Affiliation

University of Campinas (UNICAMP)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Anita J Marsaioli, Dr

Organizational Affiliation

University of Campinas (UNICAMP)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Thiago Inacio B Lopes

Organizational Affiliation

University of Campinas (UNICAMP)

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13083-878

Country

Brazil

12. IPD Sharing Statement

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Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

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