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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Jan 2011
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 18, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 24, 2012
December 1, 2010
1.9 years
May 18, 2012
May 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Cognitive decline
Up to 3 months
Quality of life
Up to 3 months
Oxidative stress
Up to 3 months
Lipid profile
Up to 3 months
Study Arms (2)
placebo group
PLACEBO COMPARATOR3 g of powdered gelatin encapsulated in opaque capsules.
Flaxseed oil group
EXPERIMENTALOil extracted from linseed by pressing the cold and encapsulated, providing 3g per day containing 1.75 g of alpha linolenic acid.
Interventions
6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Make use of some food or vitamin supplement,
- HIV positive and cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clementino Fraga Filho University Hospital Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 18, 2012
First Posted
May 24, 2012
Study Start
January 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
May 24, 2012
Record last verified: 2010-12