NCT04434534

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

June 12, 2020

Last Update Submit

June 12, 2020

Conditions

Overweight and Obesity

Keywords

Endhothelial functionAnthocyaninsArterial stiffnessAçaí Juçara

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pulse Wave Velocity

    12 weeks

Study Arms (2)

Hipocaloric Diet with Açaí Juçara

EXPERIMENTAL

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

Dietary Supplement: Hipocaloric Diet with Açaí Juçara

Hipocaloric Diet

ACTIVE COMPARATOR

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

Other: Hipocaloric Diet

Interventions

Hipocaloric Diet with Açaí JuçaraDIETARY_SUPPLEMENT

Daily consumption of Açaí Juçara pulp (200g) and nutritional adequacy of meals in individualized diet plans calculated for each participant.

Hipocaloric Diet with Açaí Juçara
Hipocaloric DietOTHER

Nutritional adequacy of meals in individualized diet plans calculated for each participant.

Hipocaloric Diet

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Alcoolism
  • Smoking
  • Diagnostic of Diabetes Mellitus or Coronary Artery Disease
  • Use of Statin Therapy
  • Cardiovascular diseases
  • Infectious Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Porto Alegre, Rio Grande do Sul, 90620001, Brazil

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tainah Ortiz

    Instituto de Cardiologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tainah Ortiz

CONTACT

55 51 999171990tainahortiz05@gmail.com

Alexandre Lehnen, PhD

CONTACT

55 51 999768092amlehnen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 17, 2020

Study Start

June 1, 2018

Primary Completion

December 10, 2020

Study Completion

December 28, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)