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Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness

Primary Purpose

Overweight and Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hipocaloric Diet with Açaí Juçara
Hipocaloric Diet
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Endhothelial function, Anthocyanins, Arterial stiffness, Açaí Juçara

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hipocaloric Diet with Açaí Juçara

Hipocaloric Diet

Arm Description

Individualized diet plans calculated for each participant, reducing 500-1000 daily calories, including 200g of Açaí Juçara (2 pulps).

Individualized diet plans calculated for each participant, reducing 500-1000 daily calories.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2020
Last Updated
June 12, 2020
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT04434534
Brief Title
Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness
Official Title
Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness in Overwheight or Obese Individuals: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 10, 2020 (Anticipated)
Study Completion Date
December 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Endhothelial function, Anthocyanins, Arterial stiffness, Açaí Juçara

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hipocaloric Diet with Açaí Juçara
Arm Type
Experimental
Arm Description
Individualized diet plans calculated for each participant, reducing 500-1000 daily calories, including 200g of Açaí Juçara (2 pulps).
Arm Title
Hipocaloric Diet
Arm Type
Active Comparator
Arm Description
Individualized diet plans calculated for each participant, reducing 500-1000 daily calories.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hipocaloric Diet with Açaí Juçara
Intervention Description
Daily consumption of Açaí Juçara pulp (200g) and nutritional adequacy of meals in individualized diet plans calculated for each participant.
Intervention Type
Other
Intervention Name(s)
Hipocaloric Diet
Intervention Description
Nutritional adequacy of meals in individualized diet plans calculated for each participant.
Primary Outcome Measure Information:
Title
Flow-mediated Dilation (FMD)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pulse Wave Velocity
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tainah Ortiz
Phone
55 51 999171990
Email
tainahortiz05@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Lehnen, PhD
Phone
55 51 999768092
Email
amlehnen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tainah Ortiz
Organizational Affiliation
Instituto de Cardiologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre M Lehnen, PhD
Phone
+555199976809
Email
amlehnen@gmail.com
First Name & Middle Initial & Last Name & Degree
Tainah Ortiz

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness

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