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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990391
• Other study ID #: 0008.0.197.185-11
• Secondary ID: U1111-1132-2061
• Status: Completed
• Phase: N/A
• First received: November 10, 2013
• Last updated: November 20, 2013
• Start date: September 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Oxidative Stress

Intervention

Dietary Supplement:
• Brazil nut flour
The Brazil nut group received 13g/day of Brazil nut flour during three months.
• Placebo (cassava flavored flour)
The group placebo (cassava flour flavored)received 9g/day of cassava flour flavored during three months

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Instituto Nacional de Cardiologia de Laranjeiras, Oswaldo Cruz Foundation, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric measures	body weight (kg), body mass index (kg/m2) and waist circumference (cm).	Change from baseline at 12 weeks	Yes
Other	Blood lipids	total Cholesterol (mg/dl), LDL-cholesterol (mg/dl), HDL-cholesterol (mg/dl) and triglycerides (mg/dl).	Change from baseline at 12 weeks	Yes
Primary	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.	Yes
Secondary	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.	Yes
Secondary	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	Yes