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Supplementation With Flaxseed Oil in the State of Rio de Janeiro

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01604681
Enrollment
200
Registered
2012-05-24
Start date
2011-01-31
Completion date
2013-12-31
Last updated
2012-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Dyslipidemia

Keywords

Linseed Oil, Oxidative Stress, Polymorphism, Genetic, Cardiovascular Diseases

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTPlacebo

6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.

DIETARY_SUPPLEMENTFlaxseed Oil

6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.

Sponsors

Rio de Janeiro State Research Supporting Foundation (FAPERJ)
CollaboratorOTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* Make use of some food or vitamin supplement, * HIV positive and cancer.

Design outcomes

Primary

MeasureTime frameDescription
PolymorphismsUp to 3 monthsTo 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.

Secondary

MeasureTime frameDescription
Cognitive declineUp to 3 monthsTo evaluate the effect of nutritional counseling associated with linseed oil supplementation on cognitive decline.
Quality of lifeUp to 3 monthsTo evaluate the effect of nutritional counseling associated with linseed oil supplementation on Quality of life.
Oxidative stressUp to 3 monthsTo evaluate the effect of nutritional counseling associated with linseed oil supplementation on biomarkers of oxidative stress.
Lipid profileUp to 3 monthsTo investigate the effect of supplementation of flaxseed oil combined with nutritional guidance on lipid profile, according to the consumption of saturated fat.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026