Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness in Overwheight or Obese Individuals: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Flow-mediated Dilation (FMD)
Study Overview
Brief Summary
This study evaluates the consumption of Açaí Juçara pulp in endothelial function and arterial stiffness in overwheight and obese individuals. Half of participants will receive a hipocaloric diet and two Açaí Juçara pulps for daily consumption, while the other half will receive just a hipocaloric diet.
Detailed Description
Obesity is the most prevalent nutritional disease and a growing public health problem worldwide. This clinical condition is an established risk factor for cardiovascular diseases.
Açaí Juçara is a brazilian fruit, rich in antioxidants, like anthocyanin. This compound have antioxidative and vasodilatory properties. Prospective studies have shown that the antioxidant present in berries can improve vascular health, like endothelial function, measured by Flow Mediated Dilatation (FMD) and arterial stiffness, measured by Pulse Wave Velocity (PWV).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Sedentary lifestyle
- •Overwheight or obesity "1" diagnostic (BMI >25kg/m² and <35kg/m²)
Exclusion Criteria
- •Alcoolism
- •Diagnostic of Diabetes Mellitus or Coronary Artery Disease
- •Use of Statin Therapy
- •Cardiovascular diseases
- •Infectious Disease
Arms & Interventions
Hipocaloric Diet with Açaí Juçara
Individualized diet plans calculated for each participant, reducing 500-1000 daily calories, including 200g of Açaí Juçara (2 pulps).
Intervention: Hipocaloric Diet with Açaí Juçara (Dietary Supplement)
Hipocaloric Diet
Individualized diet plans calculated for each participant, reducing 500-1000 daily calories.
Intervention: Hipocaloric Diet (Other)
Outcomes
Primary Outcomes
Flow-mediated Dilation (FMD)
Time Frame: 12 weeks
The non-invasive evaluation of endothelial function in the brachial artery will be performed at the Laboratory of Clinical Investigation of the Institute of Cardiology of Rio Grande do Sul. The images will be captured by a trained professional in the method using ultrasonography equipament with a linear transducer. The acquisition of the image will be through the program Ulead Video Studio (EasyCap). The protocol consist in 1 minute of baseline recording of the arterial flow diameter, followed by 5 minutes of reactive hyperemia (cuff occlusion in the forearm) and then 3 minutes recording after cuff deflation. The exams will be record in a video, and later analyzed through the Cardiovascular Suite software. The FMD will be evaluated before the beginning of the diet and after 12 weeks of diet.
Secondary Outcomes
- Pulse Wave Velocity(12 weeks)