Overweight and ObesityNCT04434534
Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness
A study testing Hipocaloric Diet with Açaí Juçara and Hipocaloric Diet in people with Overweight and Obesity, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Hipocaloric Diet with Açaí Juçara and Hipocaloric Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2018to 28 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary lifestyle
- Overwheight or obesity "1" diagnostic (BMI >25kg/m² and <35kg/m²)
Who cannot join
- Alcoolism
- Smoking
- Diagnostic of Diabetes Mellitus or Coronary Artery Disease
- Use of Statin Therapy
- Cardiovascular diseases
- Infectious Disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620001
Alexandre M Lehnen, PhD, +555199976809, amlehnen@gmail.com
Tainah Ortiz
About this study
Official title: Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness in Overwheight or Obese Individuals: A Randomized Clinical Trial
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.
Read the 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).
- Conditions
- Overweight and Obesity
- Being tested
- Hipocaloric Diet with Açaí Juçara, Hipocaloric Diet
- Keywords
- Endhothelial function, Anthocyanins, Arterial stiffness, Açaí Juçara
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 DietOther
Nutritional adequacy of meals in individualized diet plans calculated for each participant.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Hipocaloric Diet with Açaí Juçara |
| Hipocaloric Diet | Active comparator | Individualized diet plans calculated for each participant, reducing 500-1000 daily calories. Receives: Other: Hipocaloric Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Jun 2018
- Primary completion10 Dec 2020 (estimated)
- Study completion28 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tainah Ortiz, Principal investigator, Instituto de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434534
- Sponsor's protocol ID
- 5483/18
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness in Overwheight or Obese Individuals: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04434534
- Acronym / sponsor ID
- 5483/18
- Conditions
- Overweight and Obesity
- Keywords
- Endhothelial function, Anthocyanins, Arterial stiffness, Açaí Juçara
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 28 Dec 2020 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hipocaloric Diet with Açaí Juçara | Experimental | Dietary Supplement: Hipocaloric Diet with Açaí JuçaraIndividualized diet plans calculated for each participant, reducing 500-1000 daily calories, including 200g of Açaí Juçara (2 pulps). |
| Hipocaloric Diet | Active comparator | Other: Hipocaloric DietIndividualized diet plans calculated for each participant, reducing 500-1000 daily calories. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sedentary lifestyle
- Overwheight or obesity "1" diagnostic (BMI >25kg/m² and <35kg/m²)
Key exclusion criteria (6 listed)
- Alcoolism
- Smoking
- Diagnostic of Diabetes Mellitus or Coronary Artery Disease
- Use of Statin Therapy
- Cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hipocaloric Diet with Açaí JuçaraDaily consumption of Açaí Juçara pulp (200g) and nutritional adequacy of meals in individualized diet plans calculated for each participant. | Dietary supplement | Hipocaloric Diet with Açaí Juçara |
| Hipocaloric DietNutritional adequacy of meals in individualized diet plans calculated for each participant. | Other | Hipocaloric Diet |
Primary outcome
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.
1 secondary outcome
Pulse Wave Velocity
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tainah Ortiz principal investigator
Instituto de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hipocaloric Diet with Açaí Juçara and Hipocaloric Diet in people with Overweight and Obesity, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tainah Ortiz (55 51 999171990, tainahortiz05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated Dilation (FMD) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.