NCT01414465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
Last Updated

August 11, 2011

Status Verified

August 1, 2011

Enrollment Period

5 months

First QC Date

August 9, 2011

Last Update Submit

August 10, 2011

Conditions

Overweight

Keywords

Fatty acidsorlistatlipaseBMC (Body Mass Index) between 30 to 40 kg/m2Women18 to 45 yearsPremenopausal stage

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Secondary Outcomes (1)

  • Orlistat induced modulation on the Fatty Acid composition in Obese Females

    after 120 days Orlistat treatment

Study Arms (3)

low caloric diet

NO INTERVENTION

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

Drug: Orlistat

Orlistat

EXPERIMENTAL

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

Drug: Orlistat

lifestyle counseling

SHAM COMPARATOR

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

Drug: Orlistat

Interventions

OrlistatDRUG

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

Orlistatlifestyle counselinglow caloric diet

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Campinas, São Paulo, 13083-878, Brazil

Location

MeSH Terms

Conditions

Overweight

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • Bruno Geloneze, Dr

    University of Campinas (UNICAMP)

    PRINCIPAL INVESTIGATOR

  • 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)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

June 1, 2011

Last Updated

August 11, 2011

Record last verified: 2011-08

Locations

BR(1)