OverweightNCT01414465
Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females
A study testing Orlistat in people with Overweight, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Orlistat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obesity BMC (Body Mass Index) between 30 to 40 kg/m2 Women 18 to 45 years Premenopausal stage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)
Campinas, São Paulo, 13083-878
About this study
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 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Orlistat
- Keywords
- Fatty acids, orlistat, lipase, BMC (Body Mass Index) between 30 to 40 kg/m2, Women, 18 to 45 years, Premenopausal stage
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| low caloric diet | No intervention | 10 health obese women (BMI 30 to 40 kg/m2) Receives: Drug: Orlistat |
| Orlistat | Experimental | 10 obese women treated with Orlistat 120mg 3 times per day Receives: Drug: Orlistat |
| lifestyle counseling | Sham comparator | Women with BMI < 30 kg/m2, no taking drug in study Receives: Drug: Orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary 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.
Measured: after 120 days Orlistat treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Germed Pharma
- Investigators
- Bruno Geloneze, Dr, Principal investigator, University of Campinas (UNICAMP)Sabrina Nagassaki, Dr, Study chair, University of Campinas (UNICAMP)Anita J Marsaioli, Dr, Study chair, University of Campinas (UNICAMP)Thiago Inacio B Lopes, Study chair, University of Campinas (UNICAMP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414465
- Sponsor's protocol ID
- LIMED0010
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01414465
- Acronym / sponsor ID
- LIMED0010
- Conditions
- Overweight
- Keywords
- Fatty acids, orlistat, lipase, BMC (Body Mass Index) between 30 to 40 kg/m2, Women, 18 to 45 years, Premenopausal stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Germed Pharma
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low caloric diet | No intervention | Drug: Orlistat10 health obese women (BMI 30 to 40 kg/m2) |
| Orlistat | Experimental | Drug: Orlistat10 obese women treated with Orlistat 120mg 3 times per day |
| lifestyle counseling | Sham comparator | Drug: OrlistatWomen with BMI < 30 kg/m2, no taking drug in study |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obesity BMC (Body Mass Index) between 30 to 40 kg/m2 Women 18 to 45 years Premenopausal stage
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrlistatObese 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 | Drug | Orlistat, lifestyle counseling, low caloric diet |
Primary outcome
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.
1 secondary outcome
Orlistat induced modulation on the Fatty Acid composition in Obese Females
Time frame: after 120 days Orlistat treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Geloneze, Dr principal investigator
University of Campinas (UNICAMP)
Sabrina Nagassaki, Dr study chair
University of Campinas (UNICAMP)
Anita J Marsaioli, Dr study chair
University of Campinas (UNICAMP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orlistat in people with Overweight, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orlistat induced modulation on the Fatty Acid composition in Obese Females (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.