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

Primary Purpose

Dyslipidemia, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brazil nut flour
Placebo (cassava flavored flour)
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Cassava flavored flour

    Brazil nut flour

    Arm Description

    The placebo group (cassava flour flavored) received 9g/day of cassava flour flavored during three months (12 weeks)

    The Brazil nut group received 13g/day of Brazil nut flour during three months (12 weeks)

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 10, 2013
    Last Updated
    November 20, 2013
    Sponsor
    Universidade Federal do Rio de Janeiro
    Collaborators
    Instituto Nacional de Cardiologia de Laranjeiras, Oswaldo Cruz Foundation, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01990391
    Brief Title
    Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities
    Official Title
    Effect of Brazil Nut Consumption in the Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities in Hypertensive and Dyslipidemic Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio de Janeiro
    Collaborators
    Instituto Nacional de Cardiologia de Laranjeiras, Oswaldo Cruz Foundation, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia, Oxidative Stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    125 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cassava flavored flour
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo group (cassava flour flavored) received 9g/day of cassava flour flavored during three months (12 weeks)
    Arm Title
    Brazil nut flour
    Arm Type
    Experimental
    Arm Description
    The Brazil nut group received 13g/day of Brazil nut flour during three months (12 weeks)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Brazil nut flour
    Intervention Description
    The Brazil nut group received 13g/day of Brazil nut flour during three months.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo (cassava flavored flour)
    Intervention Description
    The group placebo (cassava flour flavored)received 9g/day of cassava flour flavored during three months
    Primary Outcome Measure Information:
    Title
    Antioxidant biomarker
    Description
    Change from Baseline plasma Gluthathione Peroxidase activity (nmol/min/ml) at 12 weeks, samples were stocked at -80 degrees.
    Time Frame
    Change from Baseline at 12 weeks.
    Secondary Outcome Measure Information:
    Title
    Oxidative stress biomarker
    Description
    The change from baseline plasma 8-isoprostane (pg/ml) at 12 weeks, samples were stocked at -80 degrees.
    Time Frame
    Change from Baseline at 12 weeks.
    Title
    microvascular endothelial function
    Description
    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.
    Time Frame
    Change from baseline at 12 weeks
    Other Pre-specified Outcome Measures:
    Title
    Anthropometric measures
    Description
    body weight (kg), body mass index (kg/m2) and waist circumference (cm).
    Time Frame
    Change from baseline at 12 weeks
    Title
    Blood lipids
    Description
    total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl).
    Time Frame
    Change from baseline at 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Grazielle V B Huguenin, Nutricionist
    Organizational Affiliation
    Universidade Federal do Rio de Janeiro
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26077768
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    26022214
    Citation
    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.
    Results Reference
    derived

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

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