Supplementation With Flaxseed Oil in the State of Rio de Janeiro

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01604681
• Other study ID #: 171/2011
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2012
• Last updated: May 23, 2012
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2010
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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 genotyped for the C677T and A1298C polymorphisms of methylenetetrahydrofolate reductase gene.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Dietary Supplement:
• Placebo
6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
• Flaxseed Oil
6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.

Locations

Country	Name	City	State
Brazil	Clementino Fraga Filho University Hospital Rio de Janeiro	Rio de Janeiro

Sponsors (3)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 months	No
Secondary	Cognitive decline	To evaluate the effect of nutritional counseling associated with linseed oil supplementation on cognitive decline.	Up to 3 months	No
Secondary	Quality of life	To evaluate the effect of nutritional counseling associated with linseed oil supplementation on Quality of life.	Up to 3 months	No
Secondary	Oxidative stress	To evaluate the effect of nutritional counseling associated with linseed oil supplementation on biomarkers of oxidative stress.	Up to 3 months	No
Secondary	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.	Up to 3 months	No