Supplementation With Flaxseed Oil in the State of Rio de Janeiro

Not Applicable

• Conditions: Hypertension; Dyslipidemia
• Interventions: Dietary Supplement: Flaxseed Oil; Dietary Supplement: Placebo

• Registration Number: NCT01604681
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

Study Timeline

• Status Verified: 2010-12
• Study Start: 2011-01
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-23
• Last Update Submitted: 2012-05-23
• Study First Posted: 2012-05-24
• Last Update Posted: 2012-05-24
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flaxseed oil group	Flaxseed Oil	Oil extracted from linseed by pressing the cold and encapsulated, providing 3g per day containing 1.75 g of alpha linolenic acid.
placebo group	Placebo	3 g of powdered gelatin encapsulated in opaque capsules.

Primary Outcome Measures

Name	Time	Method
Polymorphisms	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive decline	Up to 3 months	To evaluate the effect of nutritional counseling associated with linseed oil supplementation on cognitive decline.
Quality of life	Up to 3 months	To evaluate the effect of nutritional counseling associated with linseed oil supplementation on Quality of life.
Oxidative stress	Up to 3 months	To evaluate the effect of nutritional counseling associated with linseed oil supplementation on biomarkers of oxidative stress.
Lipid profile	Up to 3 months	To investigate the effect of supplementation of flaxseed oil combined with nutritional guidance on lipid profile, according to the consumption of saturated fat.

Trial Locations

Locations (1)

Clementino Fraga Filho University Hospital Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil