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Trial record 25 of 34 for:    alpha | linolenic acid

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

Tracking Information
First Submitted Date  ICMJE May 18, 2012
First Posted Date  ICMJE May 24, 2012
Last Update Posted Date May 24, 2012
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supplementation With Flaxseed Oil in the State of Rio de Janeiro
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Hypertension
  • Dyslipidemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01604681
Other Study ID Numbers  ICMJE 171/2011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ana Paula Alves Avelino, Universidade Federal do Rio de Janeiro
Study Sponsor  ICMJE Universidade Federal do Rio de Janeiro
Collaborators  ICMJE
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE Not Provided
PRS Account Universidade Federal do Rio de Janeiro
Verification Date December 2010

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