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Completed

NCT Number: NCT01990391

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

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brazil nut flour

Dietary Supplement

The Brazil nut group received 13g/day of Brazil nut flour during three months.

Placebo (cassava flavored flour)

Dietary Supplement

The group placebo (cassava flour flavored)received 9g/day of cassava flour flavored during three months

Primary outcomes

  1. Antioxidant biomarker

    Time frame: 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 outcomes

  1. Oxidative stress biomarker

    Time frame: Change from Baseline at 12 weeks.

    The change from baseline plasma 8-isoprostane (pg/ml) at 12 weeks, samples were stocked at -80 degrees.

  2. microvascular endothelial function

    Time frame: 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.

Other outcomes

  1. Anthropometric measures

    Time frame: Change from baseline at 12 weeks

    body weight (kg), body mass index (kg/m2) and waist circumference (cm).

  2. Blood lipids

    Time frame: Change from baseline at 12 weeks

    total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl).

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Instituto Nacional de Cardiologia de Laranjeiras
  • Oswaldo Cruz Foundation
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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