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

Not Applicable

Completed

• Conditions: Dyslipidemia; Oxidative Stress
• Interventions: Dietary Supplement: Brazil nut flour; Dietary Supplement: Placebo (cassava flavored flour)

• Registration Number: NCT01990391
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-11
• Study First Submitted: 2013-11-10
• Study First Submitted QC: 2013-11-14
• Last Update Submitted: 2013-11-20
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cassava flavored flour	Brazil nut flour	The placebo group (cassava flour flavored) received 9g/day of cassava flour flavored during three months (12 weeks)
Brazil nut flour	Placebo (cassava flavored flour)	The Brazil nut group received 13g/day of Brazil nut flour during three months (12 weeks)

Primary Outcome Measures

Name	Time	Method
Antioxidant biomarker	Change from Baseline at 12 weeks.	Change from Baseline plasma Gluthathione Peroxidase activity (nmol/min/ml) at 12 weeks, samples were stocked at -80 degrees.

Secondary Outcome Measures

Name	Time	Method
Oxidative stress biomarker	Change from Baseline at 12 weeks.	The change from baseline plasma 8-isoprostane (pg/ml) at 12 weeks, samples were stocked at -80 degrees.
microvascular endothelial function	Change from baseline at 12 weeks	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.