ObesityNCT00937599
Brazil Nut Consumed on the Metabolic Profile, Oxidative Stress and Nutritive Microcirculatory Patterns
A study testing Brazil Nut in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The purpose this research is to check if Brazil Nuts consumed improvement the metabolic profile, state redox and endothelial function in obese adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Brazil Nut
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Jan 2009
- 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 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- pubertal girls obese (BMI > 30 kg/m) -
Who cannot join
- Consumption of nuts Loss weight before the research chronic disease (hypertension)
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory for Clinical and Experimental Research in Vascular Biology (BioVasc), Biomedical Center, State University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
About this study
Official title: The Effect of Brazil Nut Consumed on the Metabolic Profile, Oxidative Stress and Skin Microcirculatory Patterns in Obese Female Adolescents
The purpose this research is to check if Brazil Nuts consumed improvement the metabolic profile, state redox and endothelial function in obese adolescents.
Read the detailed description
The purpose this research is to check if Brazil Nuts consumed improvement the metabolic profile (lipid profile, glucose, insulin), state redox (about glutathione peroxidase, isoprostane and LDL-ox) and endothelial function (by videocapillaroscopy) in obese adolescents (12-18 years).
- Conditions
- Obesity
- Being tested
- Brazil Nut
- Keywords
- obese, brazil nuts, oxidative stress, microcirculatory, metabolic profile
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brazil NutDietary supplement
During 16 weeks the adolescents consumed 3-5 nuts/day
| Study group | Role | What they receive |
|---|---|---|
| Brazil Nuts | Experimental | The first group consumed the brazil nuts and the other group placebo (lactose pills) Receives: Dietary Supplement: Brazil Nut |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937599
- Sponsor's protocol ID
- Biovasc - 01
- Status last verified
- Jul 2009
- First submitted
- 10 Jul 2009
- Last updated
- 14 Jul 2009
- Results posted
- No
Publications
Maranhao PA, Kraemer-Aguiar LG, de Oliveira CL, Kuschnir MC, Vieira YR, Souza MG, Koury JC, Bouskela E. Brazil nuts intake improves lipid profile, oxidative stress and microvascular function in obese adolescents: a randomized controlled trial. Nutr Metab (Lond). 2011 May 28;8(1):32. doi: 10.1186/1743-7075-8-32.
PubMed 21619692
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brazil Nut Consumed on the Metabolic Profile, Oxidative Stress and Skin Microcirculatory Patterns in Obese Female Adolescents
- ClinicalTrials.gov ID
- NCT00937599
- Acronym / sponsor ID
- Biovasc - 01
- Conditions
- Obesity
- Keywords
- obese, brazil nuts, oxidative stress, microcirculatory, metabolic profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Jul 2009 (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 if Brazil Nuts consumed improvement the metabolic profile, state redox and endothelial function in obese adolescents.
Detailed description
The purpose this research is to check if Brazil Nuts consumed improvement the metabolic profile (lipid profile, glucose, insulin), state redox (about glutathione peroxidase, isoprostane and LDL-ox) and endothelial function (by videocapillaroscopy) in obese adolescents (12-18 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brazil Nuts | Experimental | Dietary Supplement: Brazil NutThe first group consumed the brazil nuts and the other group placebo (lactose pills) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pubertal girls obese (BMI > 30 kg/m) -
Key exclusion criteria (2 listed)
- Consumption of nuts Loss weight before the research chronic disease (hypertension)
- -
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 NutDuring 16 weeks the adolescents consumed 3-5 nuts/day | Dietary supplement | Brazil Nuts |
Primary outcome
Not reported in the source record.
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 14 Jul 2009.
- Derived from this study: PubMed 21619692Maranhao PA, Kraemer-Aguiar LG, de Oliveira CL, Kuschnir MC, Vieira YR, Souza MG, Koury JC, Bouskela E. Brazil nuts intake improves lipid profile, oxidative stress and microvascular function in obese adolescents: a randomized controlled trial. Nutr Metab (Lond). 2011 May 28;8(1):32. doi: 10.1186/1743-7075-8-32.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brazil Nut in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
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 1 inclusion and 2 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 14 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00937599, which also lists 1 linked publication.
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 14 Jul 2009.