Supplementation With Flaxseed Oil in the State of Rio de Janeiro

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Universidade Federal do Rio de Janeiro.
Recruitment status was  Recruiting
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, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01604681
First received: May 18, 2012
Last updated: May 23, 2012
Last verified: December 2010
  Purpose

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.


Condition Intervention
Hypertension
Dyslipidemia
Dietary Supplement: Placebo
Dietary Supplement: Flaxseed Oil

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

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Polymorphisms [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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:
  • Cognitive decline [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    To evaluate the effect of nutritional counseling associated with linseed oil supplementation on cognitive decline.

  • Quality of life [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    To evaluate the effect of nutritional counseling associated with linseed oil supplementation on Quality of life.

  • Oxidative stress [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To investigate the effect of supplementation of flaxseed oil combined with nutritional guidance on lipid profile, according to the consumption of saturated fat.


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo group
3 g of powdered gelatin encapsulated in opaque capsules.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604681

Locations
Brazil
Clementino Fraga Filho University Hospital Rio de Janeiro Recruiting
Rio de Janeiro, Brazil
Contact: Ana Paula A Avelino    552492631394    anapaula.avelino@yahoo.com.br   
Principal Investigator: Ana Paula A Avelino         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
  More Information

No publications provided

Responsible Party: Ana Paula Alves Avelino, Principal Investigator, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01604681     History of Changes
Other Study ID Numbers: 171/2011
Study First Received: May 18, 2012
Last Updated: May 23, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
Linseed Oil
Oxidative Stress
Polymorphism, Genetic
Cardiovascular Diseases

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 01, 2014