Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities

Study Overview
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Brief Summary
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The purpose this research is to check the effect of Brazil Nuts consumption in oxidative stress, metabolic abnormalities and microvascular endothelial function dyslipidemic and hypertensive patients.

Official Title
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Effect of Brazil Nut Consumption in the Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities in Hypertensive and Dyslipidemic Subjects

Conditions
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Dyslipidemia, Oxidative Stress

Intervention / Treatment
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* Dietary Supplement: Brazil nut flour
* Dietary Supplement: Placebo (cassava flavored flour)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults > 20 years old Dyslipidemic Hypertensive Exclusion Criteria: Allergy to nuts Consumption of nuts or vitamins/minerals supplement Loss weight before the research pregnancy Kidney chronic disease

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cassava flavored flour<br>The placebo group (cassava flour flavored) received 9g/day of cassava flour flavored during three months (12 weeks) | Dietary Supplement: Brazil nut flour<br>* The Brazil nut group received 13g/day of Brazil nut flour during three months.<br>|
| Experimental: Brazil nut flour<br>The Brazil nut group received 13g/day of Brazil nut flour during three months (12 weeks) | Dietary Supplement: Placebo (cassava flavored flour)<br>* The group placebo (cassava flour flavored)received 9g/day of cassava flour flavored during three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant biomarker | Change from Baseline plasma Gluthathione Peroxidase activity (nmol/min/ml) at 12 weeks, samples were stocked at -80 degrees. | Change from Baseline at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress biomarker | The change from baseline plasma 8-isoprostane (pg/ml) at 12 weeks, samples were stocked at -80 degrees. | Change from Baseline at 12 weeks. | 
| microvascular endothelial function | Microvascular reactivity was evaluated using an Laser Speckle Contrast Imaging system with a laser wavelength of 785 nm in combination with the iontophoresis (increasing anodal currents of 30, 60, 90, 120, 150 and 180μA for 10 second intervals spaced 1 minute apart) of acetylcholine (2% v/v) for the noninvasive and continuous measurement of cutaneous microvascular perfusion changes measured in arbitrary perfusion units. | Change from baseline at 12 weeks |