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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Oxidative Stress
• Intervention / Treatment: Dietary supplement: Brazil nut flour; Dietary supplement: Placebo (cassava flavored flour)

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Cassava flavored flour; The placebo group (cassava flour flavored) received 9g/day of cassava flour flavored during three months (12 weeks)	Dietary supplement: Brazil nut flour; The Brazil nut group received 13g/day of Brazil nut flour during three months.
Experimental: Brazil nut flour; The Brazil nut group received 13g/day of Brazil nut flour during three months (12 weeks)	Dietary supplement: Placebo (cassava flavored flour); The group placebo (cassava flour flavored)received 9g/day of cassava flour flavored during three months

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measures	body weight (kg), body mass index (kg/m2) and waist circumference (cm).	Change from baseline at 12 weeks
Blood lipids	total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl).	Change from baseline at 12 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: Oswaldo Cruz Foundation; Rio de Janeiro State Research Supporting Foundation (FAPERJ); Instituto Nacional de Cardiologia de Laranjeiras
• Investigators: Principal Investigator: Grazielle V B Huguenin, Nutricionist, Universidade Federal do Rio de Janeiro

Publications and helpful links

General Publications

• Carvalho RF, Huguenin GV, Luiz RR, Moreira AS, Oliveira GM, Rosa G. Intake of partially defatted Brazil nut flour reduces serum cholesterol in hypercholesterolemic patients--a randomized controlled trial. Nutr J. 2015 Jun 16;14:59. doi: 10.1186/s12937-015-0036-x.
• Huguenin GV, Oliveira GM, Moreira AS, Saint'Pierre TD, Goncalves RA, Pinheiro-Mulder AR, Teodoro AJ, Luiz RR, Rosa G. Improvement of antioxidant status after Brazil nut intake in hypertensive and dyslipidemic subjects. Nutr J. 2015 May 29;14:54. doi: 10.1186/s12937-015-0043-y.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: November 10, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 20, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 0008.0.197.185-11; U1111-1132-2061 (Other Identifier: Universal trial number)