HypertensionNCT01604681
Supplementation With Flaxseed Oil in the State of Rio de Janeiro
A study testing Flaxseed Oil in people with Hypertension and Dyslipidemia, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effect of supplementation with flaxseed oil combined with a nutritional counseling in reducing cardiovascular risk factors in homocysteine , biomarkers of inflammation, oxidative stress, improving quality of life and cognitive decline in hypertensive and dyslipidemic… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Dyslipidemia
- What is being tested?
- Flaxseed Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Dec 2013
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of hypertension and/or dyslipidemia,
- Have over 20 years,
- Both sexes,
- Any skin color and
- Take part in the study by signing the consent form.
Who cannot join
- Make use of some food or vitamin supplement,
- HIV positive and cancer.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clementino Fraga Filho University Hospital Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
Ana Paula A Avelino, 552492631394, anapaula.avelino@yahoo.com.br
Ana Paula A Avelino
About this study
Official title: The Effect of Flaxseed Oil Supplementation on Biomarkers, Quality of Life and Cognitive Function in Hypertensive and Dyslipidemic Subjects With or Without the C677T and A1298C Polymorphisms in MTHFR Gene in Different Municipalities of Rio de Janeiro
The purpose of this study is to evaluate the effect of supplementation with flaxseed oil combined with a nutritional counseling in reducing cardiovascular risk factors in homocysteine , biomarkers of inflammation, oxidative stress, improving quality of life and cognitive decline in hypertensive and dyslipidemic genotyped for the C677T and A1298C polymorphisms of methylenetetrahydrofolate reductase gene.
Read the detailed description
Epidemiological data show that there is a decline in death from cardiovascular disease (CVD) in the state of Rio de Janeiro, but this did not happen in the cities of Itaperuna, Niterói and Volta Redonda, in spite of presenting different epidemiological characteristics, still have high rates of death CVD. What led to our interest in investigating these municipalities. Our goal is to evaluate the effect of supplementation with flaxseed oil combined with nutritional counseling in reducing cardiovascular risk factors in homocysteine, biomarkers of inflammation, oxidative stress, improving quality of life and cognitive decline in hypertensive individuals dyslipidemic and genotyped for polymorphisms C677T and A1298C methylenetetrahydrofolate reductase gene (MTFHR). This is a clinical trial, double blind, placebo-controlled, randomized block, lasting three months. Study participants will be recruited from August 2011 to August 2013. Will be recruited at least 200 individuals in each city, considering possible losses and ensuring consistent results. Subjects will be randomized in blocks of 10, five patients in the group supplemented with linseed oil and five patients in the control group with placebo supplementation, ensuring proper distribution of the number of participants in the study groups. Will be collecting information on the socio-economic status of study participants through a structured questionnaire will be carried out assessment of food consumption - frequency of consumption and 24 hours, clinic - blood pressure, anthropometric - height, weight, waist circumference and BMI, body composition - bioelectrical impedance analysis, biochemical tests - lipid profile, blood glucose, insulin, homocysteine, serum folate concentrations in erythrocytes and, cobalamin, vitamin C, E and A, minerals - zinc, iron, copper and selenium, markers of oxidative stress and inflammatory response and molecular analysis - C677T and A1298C polymorphisms of methylenetetrahydrofolate reductase gene. It will also be diagnosed with depression and evaluation of physical activity and quality of life using questionnaires were previously validated. Our results demonstrate the effectiveness of supplementation with flaxseed oil, in reinforcing the results of nutritional counseling in reducing cardiovascular risk factors and biomarkers studied, besides adding to the knowledge about the interactions between markers of inflammation, oxidative stress with oil supplementation flaxseed and polymorphisms C677T and A1298C MTHFR gene, on which there are no reports in the literature.
- Conditions
- Hypertension, Dyslipidemia
- Being tested
- Placebo, Flaxseed Oil
- Keywords
- Linseed Oil, Oxidative Stress, Polymorphism, Genetic, Cardiovascular Diseases
- Medical subject headings
- Hypertension, Dyslipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Control group
6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
Flaxseed OilDietary supplement
Also called Linseed Oil
6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | 3 g of powdered gelatin encapsulated in opaque capsules. Receives: Dietary Supplement: Placebo |
| Flaxseed oil group | Experimental | Oil extracted from linseed by pressing the cold and encapsulated, providing 3g per day containing 1.75 g of alpha linolenic acid. Receives: Dietary Supplement: Flaxseed Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphisms
To evaluate the effect of nutritional counseling associated with linseed oil supplementation on biomarkers estutados according to the C677T and A1298C polymorphisms of the MTHFR gene.
Measured: Up to 3 months
Secondary outcomes (4)
Cognitive decline
To evaluate the effect of nutritional counseling associated with linseed oil supplementation on cognitive decline.
Measured: Up to 3 months
Quality of life
To evaluate the effect of nutritional counseling associated with linseed oil supplementation on Quality of life.
Measured: Up to 3 months
Oxidative stress
To evaluate the effect of nutritional counseling associated with linseed oil supplementation on biomarkers of oxidative stress.
Measured: Up to 3 months
Lipid profile
To investigate the effect of supplementation of flaxseed oil combined with nutritional guidance on lipid profile, according to the consumption of saturated fat.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Ana Paula Alves Avelino, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604681
- Sponsor's protocol ID
- 171/2011
- Status last verified
- Dec 2010
- First submitted
- 18 May 2012
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Flaxseed Oil Supplementation on Biomarkers, Quality of Life and Cognitive Function in Hypertensive and Dyslipidemic Subjects With or Without the C677T and A1298C Polymorphisms in MTHFR Gene in Different Municipalities of Rio de Janeiro
- ClinicalTrials.gov ID
- NCT01604681
- Acronym / sponsor ID
- 171/2011
- Conditions
- Hypertension, Dyslipidemia
- Keywords
- Linseed Oil, Oxidative Stress, Polymorphism, Genetic, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 May 2012 (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.
The purpose of this study is to evaluate the effect of supplementation with flaxseed oil combined with a nutritional counseling in reducing cardiovascular risk factors in homocysteine , biomarkers of inflammation, oxidative stress, improving quality of life and cognitive decline in hypertensive and dyslipidemic genotyped for the C677T and A1298C polymorphisms of methylenetetrahydrofolate reductase gene.
Detailed description
Epidemiological data show that there is a decline in death from cardiovascular disease (CVD) in the state of Rio de Janeiro, but this did not happen in the cities of Itaperuna, Niterói and Volta Redonda, in spite of presenting different epidemiological characteristics, still have high rates of death CVD. What led to our interest in investigating these municipalities. Our goal is to evaluate the effect of supplementation with flaxseed oil combined with nutritional counseling in reducing cardiovascular risk factors in homocysteine, biomarkers of inflammation, oxidative stress, improving quality of life and cognitive decline in hypertensive individuals dyslipidemic and genotyped for polymorphisms C677T and A1298C methylenetetrahydrofolate reductase gene (MTFHR). This is a clinical trial, double blind, placebo-controlled, randomized block, lasting three months. Study participants will be recruited from August 2011 to August 2013. Will be recruited at least 200 individuals in each city, considering possible losses and ensuring consistent results. Subjects will be randomized in blocks of 10, five patients in the group supplemented with linseed oil and five patients in the control group with placebo supplementation, ensuring proper distribution of the number of participants in the study groups. Will be collecting information on the socio-economic status of study participants through a structured questionnaire will be carried out assessment of food consumption - frequency of consumption and 24 hours, clinic - blood pressure, anthropometric - height, weight, waist circumference and BMI, body composition - bioelectrical impedance analysis, biochemical tests - lipid profile, blood glucose, insulin, homocysteine, serum folate concentrations in erythrocytes and, cobalamin, vitamin C, E and A, minerals - zinc, iron, copper and selenium, markers of oxidative stress and inflammatory response and molecular analysis - C677T and A1298C polymorphisms of methylenetetrahydrofolate reductase gene. It will also be diagnosed with depression and evaluation of physical activity and quality of life using questionnaires were previously validated. Our results demonstrate the effectiveness of supplementation with flaxseed oil, in reinforcing the results of nutritional counseling in reducing cardiovascular risk factors and biomarkers studied, besides adding to the knowledge about the interactions between markers of inflammation, oxidative stress with oil supplementation flaxseed and polymorphisms C677T and A1298C MTHFR gene, on which there are no reports in the literature.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Dietary Supplement: Placebo3 g of powdered gelatin encapsulated in opaque capsules. |
| Flaxseed oil group | Experimental | Dietary Supplement: Flaxseed OilOil extracted from linseed by pressing the cold and encapsulated, providing 3g per day containing 1.75 g of alpha linolenic acid. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of hypertension and/or dyslipidemia,
- Have over 20 years,
- Both sexes,
- Any skin color and
- Take part in the study by signing the consent form.
Key exclusion criteria (2 listed)
- Make use of some food or vitamin supplement,
- HIV positive and cancer.
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: Control group6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time. | Dietary supplement | placebo group |
| Flaxseed OilAlso: Linseed Oil6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time. | Dietary supplement | Flaxseed oil group |
Primary outcome
Polymorphisms
Time frame: Up to 3 months
To evaluate the effect of nutritional counseling associated with linseed oil supplementation on biomarkers estutados according to the C677T and A1298C polymorphisms of the MTHFR gene.
4 secondary outcomes
Cognitive decline
Time frame: Up to 3 months
Quality of life
Time frame: Up to 3 months
Oxidative stress
Time frame: Up to 3 months
Lipid profile
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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.
Clementino Fraga Filho University Hospital Rio de Janeiro
Rio de Janeiro, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed Oil in people with Hypertension and Dyslipidemia, run by Universidade Federal do Rio de Janeiro 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 5 inclusion and 2 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 24 May 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polymorphisms (time frame: Up to 3 months). 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 24 May 2012.