Morbid ObesityPhase 2NCT00502021
Use of Flaxseed(Alpha Linolenic Acid) Powder in Morbidly Obese Patients With Systemic Inflammation
A Phase 2 study testing Alpha-linolenic acid/ALA and Alpha linolenic acid/ALA in people with Morbid Obesity and Atherosclerosis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic acid,is beneficial for the general inflammation present in morbidly obese subjects by decreasing elevated serum markers.As omega-3 fatty acids display additional properties including possible amelioration of atherosclerosis,a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Atherosclerosis, Systemic Inflammation
- What is being tested?
- Alpha-linolenic acid/ALA and Alpha linolenic acid/ALA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Oct 2013
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females
- 18- 65 years old
- Body mass index/BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities)
- Non-hospitalized and receiving general oral diet
- With elevated C-reactive protein/ CRP (> 5mg/L); and
- Signing informed consent
Who cannot join
- SIRS, shock, coma or organ failure,
- Fever or infectious foci
- Cancer with or without chemo/radiotherapy
- Inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases
- Trauma, surgery or hospitalization in the last 30 days
- Use of steroidal or non-steroidal anti-inflammatory or immune-modulating agents or antibiotics; and
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas-ICHC-9th Floor- Av. Eneias C. Aguiar 255
São Paulo, São Paulo, 05403-900
Patricia C Marques, MD, 5511-30697561 ext. 18, patipaticamar@hotmail.com
Ivan Cecconello, MD,PhD
About this study
Official title: Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid
Preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic acid,is beneficial for the general inflammation present in morbidly obese subjects by decreasing elevated serum markers.As omega-3 fatty acids display additional properties including possible amelioration of atherosclerosis,a 3-month supplementation protocol was devised.Arterial stiffness and intima thickness will be measured in severely obese subjects, in order to document possible reduction of these variables as well.
Read the detailed description
Population:Morbidly obese non-smoking patients of the Department of Gastroenterology, candidates for possible bariatric treatment Criteria for inclusion: Males and females, 18- 65 years old, body mass index/BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities), non-hospitalized and receiving general oral diet, with elevated C-reactive protein/ CRP (> 5mg/L), and signing informed consent; Criteria for exclusion: SIRS, shock, coma or organ failure, fever or infectious foci, cancer with or without chemo/radiotherapy, inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases, trauma, surgery or hospitalization in the last 30 days, use of steroidal or non-steroidal anti-inflammatory or immune-modulating agents or antibiotics, and refusal to participate in the study; Dietetic routine: Daily flaxseed powder (Farinha de linhaca dourada) 60 g/day (232 kcal , containing 10 g of alpha-linolenic acid/ALA) or placebo (commercial manioc flour 60 g/day, 120 kcal)) during 12 weeks. An additional 60 subjects (30 patients, 30 controls) will ve managed with 30 ml/day flaxseed oil (10 g of alpha-linolenic acid/ALA) or 30 ml/day placebo (safflower oil).
Methods: Clinical questionnaire,nutritional assessment(Weight, height, BMI) Biochemical tests: Hemoglobin (HB) , white blood cell count (WBC), total cholesterol (CHOL) and fractions (HDL, LDL, VLDL), triglycerides (TRIG), blood glucose (GLU), serum albumin (ALB),insulin (INS), leptin (LEP),C-reactive protein (CRP), serum amyloid A (SAA), complement fractions C3 and C4, coagulation profile Atherosclerosis markers: Arterial stiffness (aorta) and intima thickness (common carotid artery)
- Conditions
- Morbid Obesity, Atherosclerosis, Systemic Inflammation
- Being tested
- Placebo, Alpha-linolenic acid/ALA, Alpha linolenic acid/ALA
- Keywords
- obesity, alpha linolenic acid, flaxseed, C-reactive protein, inflammation
- Medical subject headings
- Obesity, Morbid, Atherosclerosis, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Cassava powder
Manioc powder (placebo) 60 g/day
Alpha-linolenic acid/ALADietary supplement
Also called Linseed powder, omega- 3 fatty acid
Flaxseed powder 60 g/day (10 g ALA)
Alpha linolenic acid/ALADietary supplement
Also called Linseed oil, omega- 3 fatty acid
Flaxseed oil 30 ml/day (10 g ALA)
PlaceboDietary supplement
Also called Omega 6 fatty acids
Safflower oil 30 ml/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Supplement of flaxseed powder (60 g/day)during 12 weeks Receives: Dietary Supplement: Alpha-linolenic acid/ALA |
| 2 | Placebo comparator | Placebo powder supplement 60 g/day during 12 weeks Receives: Dietary Supplement: Placebo |
| 3 | Experimental | Flaxseed oil 30 ml/day (10 g ALA)during 12 weeks Receives: Dietary Supplement: Alpha linolenic acid/ALA |
| 4 | Placebo comparator | Safflower oil 30 ml/day (no ALA) during 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in arterial stiffness/intima thickness
Measured: 12 weeks
Secondary outcomes (1)
Improvement in inflammatory markers and serum lipids
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Faintuch, University of Sao Paulo
- Investigators
- Joel Faintuch, MD,PhD, Study chair, Sao Paulo University Medical SchoolPatricia C Marques, MD, Principal investigator, Hospital das Clinicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502021
- Sponsor's protocol ID
- Flaxseed01
- Status last verified
- Sep 2012
- First submitted
- 16 Jul 2007
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Faintuch J, Horie LM, Barbeiro HV, Barbeiro DF, Soriano FG, Ishida RK, Cecconello I. Systemic inflammation in morbidly obese subjects: response to oral supplementation with alpha-linolenic acid. Obes Surg. 2007 Mar;17(3):341-7. doi: 10.1007/s11695-007-9062-x.
PubMed 17546842Faintuch J, Horie LM, Schmidt VD, Barbeiro HV, Barbeiro DF, Soriano FG, Cecconello I. Obesity, inflammation, vascular reactivity, and cardiocirculatory events. Clinics (Sao Paulo). 2007 Jun;62(3):357-8. doi: 10.1590/s1807-59322007000300023. No abstract available.
PubMed 17589679
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid
- ClinicalTrials.gov ID
- NCT00502021
- Acronym / sponsor ID
- Flaxseed01
- Conditions
- Morbid Obesity, Atherosclerosis, Systemic Inflammation
- Keywords
- obesity, alpha linolenic acid, flaxseed, C-reactive protein, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 17 Jul 2007 (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.
Preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic acid,is beneficial for the general inflammation present in morbidly obese subjects by decreasing elevated serum markers.As omega-3 fatty acids display additional properties including possible amelioration of atherosclerosis,a 3-month supplementation protocol was devised.Arterial stiffness and intima thickness will be measured in severely obese subjects, in order to document possible reduction of these variables as well.
Detailed description
Population:Morbidly obese non-smoking patients of the Department of Gastroenterology, candidates for possible bariatric treatment Criteria for inclusion: Males and females, 18- 65 years old, body mass index/BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities), non-hospitalized and receiving general oral diet, with elevated C-reactive protein/ CRP (> 5mg/L), and signing informed consent; Criteria for exclusion: SIRS, shock, coma or organ failure, fever or infectious foci, cancer with or without chemo/radiotherapy, inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases, trauma, surgery or hospitalization in the last 30 days, use of steroidal or non-steroidal anti-inflammatory or immune-modulating agents or antibiotics, and refusal to participate in the study; Dietetic routine: Daily flaxseed powder (Farinha de linhaca dourada) 60 g/day (232 kcal , containing 10 g of alpha-linolenic acid/ALA) or placebo (commercial manioc flour 60 g/day, 120 kcal)) during 12 weeks. An additional 60 subjects (30 patients, 30 controls) will ve managed with 30 ml/day flaxseed oil (10 g of alpha-linolenic acid/ALA) or 30 ml/day placebo (safflower oil).
Methods: Clinical questionnaire,nutritional assessment(Weight, height, BMI) Biochemical tests: Hemoglobin (HB) , white blood cell count (WBC), total cholesterol (CHOL) and fractions (HDL, LDL, VLDL), triglycerides (TRIG), blood glucose (GLU), serum albumin (ALB),insulin (INS), leptin (LEP),C-reactive protein (CRP), serum amyloid A (SAA), complement fractions C3 and C4, coagulation profile Atherosclerosis markers: Arterial stiffness (aorta) and intima thickness (common carotid artery)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Alpha-linolenic acid/ALASupplement of flaxseed powder (60 g/day)during 12 weeks |
| 2 | Placebo comparator | Dietary Supplement: PlaceboPlacebo powder supplement 60 g/day during 12 weeks |
| 3 | Experimental | Dietary Supplement: Alpha linolenic acid/ALAFlaxseed oil 30 ml/day (10 g ALA)during 12 weeks |
| 4 | Placebo comparator | Dietary Supplement: PlaceboSafflower oil 30 ml/day (no ALA) during 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females
- 18- 65 years old
- Body mass index/BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities)
- Non-hospitalized and receiving general oral diet
- With elevated C-reactive protein/ CRP (> 5mg/L); and
Key exclusion criteria (7 listed)
- SIRS, shock, coma or organ failure,
- Fever or infectious foci
- Cancer with or without chemo/radiotherapy
- Inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases
- Trauma, surgery or hospitalization in the last 30 days
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 |
|---|---|---|
| PlaceboAlso: Cassava powderManioc powder (placebo) 60 g/day | Dietary supplement | 2 |
| Alpha-linolenic acid/ALAAlso: Linseed powder, omega- 3 fatty acidFlaxseed powder 60 g/day (10 g ALA) | Dietary supplement | 1 |
| Alpha linolenic acid/ALAAlso: Linseed oil, omega- 3 fatty acidFlaxseed oil 30 ml/day (10 g ALA) | Dietary supplement | 3 |
| PlaceboAlso: Omega 6 fatty acidsSafflower oil 30 ml/day | Dietary supplement | 4 |
Primary outcome
Reduction in arterial stiffness/intima thickness
Time frame: 12 weeks
1 secondary outcome
Improvement in inflammatory markers and serum lipids
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2012.
- Background: PubMed 17546842Faintuch J, Horie LM, Barbeiro HV, Barbeiro DF, Soriano FG, Ishida RK, Cecconello I. Systemic inflammation in morbidly obese subjects: response to oral supplementation with alpha-linolenic acid. Obes Surg. 2007 Mar;17(3):341-7. doi: 10.1007/s11695-007-9062-x.
- Background: PubMed 17589679Faintuch J, Horie LM, Schmidt VD, Barbeiro HV, Barbeiro DF, Soriano FG, Cecconello I. Obesity, inflammation, vascular reactivity, and cardiocirculatory events. Clinics (Sao Paulo). 2007 Jun;62(3):357-8. doi: 10.1590/s1807-59322007000300023. No abstract available.
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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.
Joel Faintuch, MD,PhD study chair
Sao Paulo University Medical School
Patricia C Marques, MD principal investigator
Hospital das Clinicas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpha-linolenic acid/ALA and Alpha linolenic acid/ALA in people with Morbid Obesity and Atherosclerosis, run by University of Sao Paulo 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joel Faintuch (5511- 330697561 ext. 18, jfaintuch@hcnet.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in arterial stiffness/intima thickness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00502021, which also lists 2 linked publications.
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 28 Sep 2012.