NCT01990391

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

November 10, 2013

Last Update Submit

November 20, 2013

Conditions

DyslipidemiaOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Oxidative stress biomarker

    Change from Baseline at 12 weeks.

  • microvascular endothelial function

    Change from baseline at 12 weeks

Other Outcomes (2)

  • Anthropometric measures

    Change from baseline at 12 weeks

  • Blood lipids

    Change from baseline at 12 weeks

Study Arms (2)

Cassava flavored flour

PLACEBO COMPARATOR

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

Dietary Supplement: Brazil nut flour

Brazil nut flour

EXPERIMENTAL

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

Dietary Supplement: Placebo (cassava flavored flour)

Interventions

Brazil nut flourDIETARY_SUPPLEMENT

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

Cassava flavored flour
Placebo (cassava flavored flour)DIETARY_SUPPLEMENT

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

Brazil nut flour

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults \> 20 years old
  • Dyslipidemic
  • Hypertensive

You may not qualify if:

  • Allergy to nuts
  • Consumption of nuts or vitamins/minerals supplement
  • Loss weight before the research
  • pregnancy
  • Kidney chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26077768DERIVED

  • 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.

    PMID: 26022214DERIVED

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Grazielle V B Huguenin, Nutricionist

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mrs

Study Record Dates

First Submitted

November 10, 2013

First Posted

November 21, 2013

Study Start

September 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11