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Completed

NCT Number: NCT01453166

Brazilian Heart-Prevent Meal - 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.

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Key information

Conditions

Cardiovascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital do Coracao

São Paulo, 04005000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Brazilian heart-prevent meal

Other

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

Other names: Dietetic intervation developed by reseachers

Heart prevent control meal weekly

Other

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

Other names: Dietetic intervation

Heart prevent control Meal monthly

Other

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.

Other names: Dietetic intervation once per month

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 12 weeks

    Change From Baseline in systolic blood pressure

  2. Total Cholesterol

    Time frame: 12 weeks

    Change From Baseline in total Cholesterol

Secondary outcomes

  1. Weight

    Time frame: 12 weeks

    Change From Baseline in weight

  2. Waist Circumference

    Time frame: 12 weeks

    Change From Baseline in wais circumference

  3. Blood Glucose

    Time frame: 12 weeks

    Change From Baseline in blood glucose

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

The Effect of Brazilian Heart Prevent Meal Program Accessible for the Population to Prevent New Cardiovascular Events: A Pilot Randomized Clinical Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 17, 2011
Registry last updated
Jul 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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