Cardiovascular DiseasesNCT01453166
Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial
A study testing Brazilian heart-prevent meal in people with Cardiovascular Diseases, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Brazilian heart-prevent meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any coronary artery disease evidence in the past 10 years; or any ischemic stroke or TIA evidence in the past 10 years; or peripheral arterial disease in the past 10 years; or at least one of the following additional risk factors:
- Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history;
- Asymptomatic carotid artery disease;
- Body mass index> 25 kg/m2 for adults and> 28 kg/m2 for seniors
Who cannot join
- Neurocognitive or psychiatric condition;
- Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators).
- Pregnancy or breast feeding.
- Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal
- Renal impairment defined as creatinine values higher than 1.5 mg/dL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial
The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events.
Read the detailed description
Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide. Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease. This pilot trial is based on specific and traditional brazilian food. The objective is to reduce risk factors such as obesity, high blood pressure,dyslipidemia and diabetes in patients with cardiovascular disease history.
- Conditions
- Cardiovascular Diseases
- Being tested
- Brazilian heart-prevent meal, Heart prevent control meal weekly, Heart prevent control Meal monthly
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brazilian heart-prevent mealOther
Also called Dietetic intervation developed by reseachers
Nutrient profile of the diets used was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, all foods included in the menu were low-cost and widely available at local markets
Heart prevent control meal weeklyOther
Also called Dietetic intervation
received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
Heart prevent control Meal monthlyOther
Also called Dietetic intervation once per month
received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Nutrient profile of the diets used was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, all foods included in the menu were low-cost and widely available at local markets Receives: Other: Brazilian heart-prevent meal |
| Group 2 | Experimental | Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions Receives: Other: Heart prevent control meal weekly |
| Group 3 | Experimental | Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions. Receives: Other: Heart prevent control Meal monthly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Change From Baseline in systolic blood pressure
Measured: 12 weeks
Total Cholesterol
Change From Baseline in total Cholesterol
Measured: 12 weeks
Secondary outcomes (3)
Weight
Change From Baseline in weight
Measured: 12 weeks
Waist Circumference
Change From Baseline in wais circumference
Measured: 12 weeks
Blood Glucose
Change From Baseline in blood glucose
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Bernardete Weber, PhD, Principal investigator, Hospital do Coração
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453166
- Sponsor's protocol ID
- 01/2011
- Status last verified
- Jul 2012
- First submitted
- 11 Oct 2011
- Last updated
- 19 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Weber B, Galante AP, Bersch-Ferreira AC, Torreglosa CR, Carvalho VO, Victor Eda S, Espirito-Santo JA, Ross-Fernandes MB, Soares RM, Costa RP, Lara Ede S, Buehler AM, Berwanger O. Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial. Clinics (Sao Paulo). 2012 Dec;67(12):1407-14. doi: 10.6061/clinics/2012(12)10.
PubMed 23295594
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01453166
- Acronym / sponsor ID
- 01/2011
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Posted 17 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of a brazilian cardioprotective diet plan to reduce cardiovascular risk factors of new cardiovascular events.
Detailed description
Cardiovascular diseases are the leading cause of mortality in both sexes in Brazil and worldwide. Modifying risk factors such as diet and lifestyle can prevent most cases of cardiovascular disease. This pilot trial is based on specific and traditional brazilian food. The objective is to reduce risk factors such as obesity, high blood pressure,dyslipidemia and diabetes in patients with cardiovascular disease history.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Brazilian heart-prevent mealNutrient profile of the diets used was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, all foods included in the menu were low-cost and widely available at local markets |
| Group 2 | Experimental | Other: Heart prevent control meal weeklyGroup B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions |
| Group 3 | Experimental | Other: Heart prevent control Meal monthlyGroup C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any coronary artery disease evidence in the past 10 years; or any ischemic stroke or TIA evidence in the past 10 years; or peripheral arterial disease in the past 10 years; or at least one of the following additional risk factors:
- Diabetes Mellitus; Hypertension; Dyslipidemia; Coronary artery disease family history;
- Asymptomatic carotid artery disease;
- Body mass index> 25 kg/m2 for adults and> 28 kg/m2 for seniors
Key exclusion criteria (5 listed)
- Neurocognitive or psychiatric condition;
- Life expectancy less than 6 months (eg, metastatic malignancy or other defined as clinical trial investigators).
- Pregnancy or breast feeding.
- Hepatic impairment defined as elevated liver enzymes above three times the upper limit of normal
- Renal impairment defined as creatinine values higher than 1.5 mg/dL.
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 |
|---|---|---|
| Brazilian heart-prevent mealAlso: Dietetic intervation developed by reseachersNutrient profile of the diets used was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, all foods included in the menu were low-cost and widely available at local markets | Other | Group 1 |
| Heart prevent control meal weeklyAlso: Dietetic intervationreceived the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions | Other | Group 2 |
| Heart prevent control Meal monthlyAlso: Dietetic intervation once per monthreceived the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions. | Other | Group 3 |
Primary outcome
Systolic Blood Pressure
Time frame: 12 weeks
Change From Baseline in systolic blood pressure
Total Cholesterol
Time frame: 12 weeks
Change From Baseline in total Cholesterol
3 secondary outcomes
Weight
Time frame: 12 weeks
Waist Circumference
Time frame: 12 weeks
Blood Glucose
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23295594Weber B, Galante AP, Bersch-Ferreira AC, Torreglosa CR, Carvalho VO, Victor Eda S, Espirito-Santo JA, Ross-Fernandes MB, Soares RM, Costa RP, Lara Ede S, Buehler AM, Berwanger O. Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial. Clinics (Sao Paulo). 2012 Dec;67(12):1407-14. doi: 10.6061/clinics/2012(12)10.
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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.
Bernardete Weber, PhD principal investigator
Hospital do Coração
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brazilian heart-prevent meal in people with Cardiovascular Diseases, run by Hospital do Coracao 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 4 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 19 Jul 2012. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Systolic Blood Pressure (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT01453166, 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 19 Jul 2012.