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Supplementation With Flaxseed Oil in the State of Rio de Janeiro

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ClinicalTrials.gov Identifier: NCT01604681
Recruitment Status : Unknown
Verified December 2010 by Ana Paula Alves Avelino, Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
First Posted : May 24, 2012
Last Update Posted : May 24, 2012
Sponsor:
Collaborators:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Ana Paula Alves Avelino, Universidade Federal do Rio de Janeiro

May 18, 2012
May 24, 2012
May 24, 2012
January 2011
December 2012   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • Cognitive decline [ Time Frame: Up to 3 months ]
    To evaluate the effect of nutritional counseling associated with linseed oil supplementation on cognitive decline.
  • Quality of life [ Time Frame: Up to 3 months ]
    To evaluate the effect of nutritional counseling associated with linseed oil supplementation on Quality of life.
  • Oxidative stress [ Time Frame: Up to 3 months ]
    To evaluate the effect of nutritional counseling associated with linseed oil supplementation on biomarkers of oxidative stress.
  • Lipid profile [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
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
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
  • Hypertension
  • Dyslipidemia
  • Dietary Supplement: Placebo
    6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
    Other Name: Control group
  • Dietary Supplement: Flaxseed Oil
    6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
    Other Name: Linseed Oil
  • Placebo Comparator: placebo group
    3 g of powdered gelatin encapsulated in opaque capsules.
    Intervention: Dietary Supplement: Placebo
  • Experimental: Flaxseed oil group
    Oil extracted from linseed by pressing the cold and encapsulated, providing 3g per day containing 1.75 g of alpha linolenic acid.
    Intervention: Dietary Supplement: Flaxseed Oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Same as current
December 2013
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 90 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01604681
171/2011
Yes
Not Provided
Not Provided
Ana Paula Alves Avelino, Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
Not Provided
Universidade Federal do Rio de Janeiro
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP