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

NCT ID: NCT01990391

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemia Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cassava flavored flour

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

Group Type PLACEBO_COMPARATOR

Brazil nut flour

Intervention Type DIETARY_SUPPLEMENT

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

Brazil nut flour

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

Group Type EXPERIMENTAL

Placebo (cassava flavored flour)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Brazil nut flour

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

Intervention Type DIETARY_SUPPLEMENT

Placebo (cassava flavored flour)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Nacional de Cardiologia de Laranjeiras

OTHER

Sponsor Role collaborator

Oswaldo Cruz Foundation

OTHER

Sponsor Role collaborator

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Grazielle Vilas Boas Huguenin

Mrs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grazielle V B Huguenin, Nutricionist

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

References

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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.

Reference Type DERIVED
PMID: 26077768 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26022214 (View on PubMed)

Other Identifiers

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U1111-1132-2061

Identifier Type: OTHER

Identifier Source: secondary_id

0008.0.197.185-11

Identifier Type: -

Identifier Source: org_study_id