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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01990391
Enrollment
125
Registered
2013-11-21
Start date
2011-09-30
Completion date
2013-04-30
Last updated
2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Oxidative Stress

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.

Interventions

DIETARY_SUPPLEMENTBrazil nut flour

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

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

Sponsors

Instituto Nacional de Cardiologia de Laranjeiras
CollaboratorOTHER
Oswaldo Cruz Foundation
CollaboratorOTHER
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
CollaboratorOTHER_GOV
Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Antioxidant biomarkerChange 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

MeasureTime frameDescription
Oxidative stress biomarkerChange 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 functionChange from baseline at 12 weeksMicrovascular 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

MeasureTime frameDescription
Anthropometric measuresChange from baseline at 12 weeksbody weight (kg), body mass index (kg/m2) and waist circumference (cm).
Blood lipidsChange from baseline at 12 weekstotal Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026