Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness

Overweight and Obesity Clinical Trial

Official title:

Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness in Overwheight or Obese Individuals: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04434534
• Other study ID #: 5483/18
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 28, 2020

Study information

• Verified date: June 2020
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Tainah Ortiz
• Phone: 55 51 999171990
• Email: tainahortiz05[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 28, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Sedentary lifestyle

• Overwheight or obesity "1" diagnostic (BMI >25kg/m² and <35kg/m²)

Exclusion Criteria:

• Alcoolism

• Smoking

• Diagnostic of Diabetes Mellitus or Coronary Artery Disease

• Use of Statin Therapy

• Cardiovascular diseases

• Infectious Disease

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Hipocaloric Diet with Açaí Juçara
Daily consumption of Açaí Juçara pulp (200g) and nutritional adequacy of meals in individualized diet plans calculated for each participant.

Other:
• Hipocaloric Diet
Nutritional adequacy of meals in individualized diet plans calculated for each participant.

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated Dilation (FMD)	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.	12 weeks
Secondary	Pulse Wave Velocity	The calibrated and validated Mobil-O-Graph® portable monitor will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch.; All measurements will be performed by the same evaluator on the right side of the volunteer. Participants will be instructed to be in 12 hours os fasting.; The pulse wave velocity will be evaluated before the beginning of the diet and after 12 weeks of diet.	12 weeks