DyslipidemiaNCT01990391
Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities
A study testing Brazil nut flour in people with Dyslipidemia and Oxidative Stress, run by Universidade Federal do Rio de Janeiro.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Oxidative Stress
- What is being tested?
- Brazil nut flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults > 20 years old
- Dyslipidemic
- Hypertensive
Who cannot join
- Allergy to nuts
- Consumption of nuts or vitamins/minerals supplement
- Loss weight before the research
- pregnancy
- Kidney chronic disease
About this study
Official title: Effect of Brazil Nut Consumption in the Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities in Hypertensive and Dyslipidemic Subjects
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.
- Conditions
- Dyslipidemia, Oxidative Stress
- Being tested
- Brazil nut flour, Placebo (cassava flavored flour)
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brazil nut flourDietary supplement
The Brazil nut group received 13g/day of Brazil nut flour during three months.
Placebo (cassava flavored flour)Dietary supplement
The group placebo (cassava flour flavored)received 9g/day of cassava flour flavored during three months
| Study group | Role | What they receive |
|---|---|---|
| Cassava flavored flour | Placebo comparator | The placebo group (cassava flour flavored) received 9g/day of cassava flour flavored during three months (12 weeks) Receives: 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) Receives: Dietary Supplement: Placebo (cassava flavored flour) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant biomarker
Change from Baseline plasma Gluthathione Peroxidase activity (nmol/min/ml) at 12 weeks, samples were stocked at -80 degrees.
Measured: Change from Baseline at 12 weeks.
Secondary outcomes (2)
Oxidative stress biomarker
The change from baseline plasma 8-isoprostane (pg/ml) at 12 weeks, samples were stocked at -80 degrees.
Measured: Change from Baseline at 12 weeks.
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.
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia de Laranjeiras, Oswaldo Cruz Foundation, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Grazielle Vilas Boas Huguenin, Universidade Federal do Rio de Janeiro
- Investigators
- Grazielle V B Huguenin, Nutricionist, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990391
- Sponsor's protocol ID
- 0008.0.197.185-11
- Other IDs
- U1111-1132-2061
- Status last verified
- Nov 2013
- First submitted
- 10 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26077768Huguenin 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.
PubMed 26022214
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brazil Nut Consumption in the Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities in Hypertensive and Dyslipidemic Subjects
- ClinicalTrials.gov ID
- NCT01990391
- Acronym / sponsor ID
- 0008.0.197.185-11
- Conditions
- Dyslipidemia, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia de Laranjeiras, Oswaldo Cruz Foundation, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cassava flavored flour | Placebo comparator | Dietary Supplement: Brazil nut flourThe placebo group (cassava flour flavored) received 9g/day of cassava flour flavored during three months (12 weeks) |
| Brazil nut flour | Experimental | Dietary Supplement: Placebo (cassava flavored flour)The Brazil nut group received 13g/day of Brazil nut flour during three months (12 weeks) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults > 20 years old
- Dyslipidemic
- Hypertensive
Key exclusion criteria (5 listed)
- Allergy to nuts
- Consumption of nuts or vitamins/minerals supplement
- Loss weight before the research
- pregnancy
- Kidney chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brazil nut flourThe Brazil nut group received 13g/day of Brazil nut flour during three months. | Dietary supplement | Cassava flavored flour |
| Placebo (cassava flavored flour)The group placebo (cassava flour flavored)received 9g/day of cassava flour flavored during three months | Dietary supplement | Brazil nut flour |
Primary outcome
Antioxidant biomarker
Time frame: Change from Baseline at 12 weeks.
Change from Baseline plasma Gluthathione Peroxidase activity (nmol/min/ml) at 12 weeks, samples were stocked at -80 degrees.
2 secondary outcomes
Oxidative stress biomarker
Time frame: Change from Baseline at 12 weeks.
microvascular endothelial function
Time frame: Change from baseline at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 26077768Carvalho 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.
- Derived from this study: PubMed 26022214Huguenin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grazielle V B Huguenin, Nutricionist principal investigator
Universidade Federal do Rio de Janeiro
Questions about this trial
What is this clinical trial studying?
A study testing Brazil nut flour in people with Dyslipidemia and Oxidative Stress, run by Universidade Federal do Rio de Janeiro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant biomarker (time frame: Change from Baseline at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990391, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.