Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453166
• Other study ID #: 01/2011
• Status: Completed
• Phase: N/A
• First received: October 11, 2011
• Last updated: July 16, 2012
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Brazilian heart-prevent meal
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 weekly
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 monthly
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.

Locations

Country	Name	City	State
Brazil	Hospital do Coracao	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Change From Baseline in systolic blood pressure	12 weeks	Yes
Primary	Total Cholesterol	Change From Baseline in total Cholesterol	12 weeks	Yes
Secondary	Weight	Change From Baseline in weight	12 weeks	Yes
Secondary	Waist Circumference	Change From Baseline in wais circumference	12 weeks	Yes
Secondary	Blood Glucose	Change From Baseline in blood glucose	12 weeks	No