Brazilian Heart-Prevent Meal - A Pilot Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT01453166
• Lead Sponsor: Hospital do Coracao

Brief 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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-17
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Results First Submitted: 2012-03-15
• Results First Submitted QC: 2012-06-13
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Results First Posted: 2012-07-17
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	12 weeks	Change From Baseline in systolic blood pressure
Total Cholesterol	12 weeks	Change From Baseline in total Cholesterol

Secondary Outcome Measures

Name	Time	Method
Weight	12 weeks	Change From Baseline in weight
Waist Circumference	12 weeks	Change From Baseline in wais circumference
Blood Glucose	12 weeks	Change From Baseline in blood glucose

Trial Locations

Locations (1)

Hospital do Coracao; 🇧🇷 Sao Paulo, Brazil