Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors

December 2, 2014 updated by: Mauara Scorsatto, Universidade Federal do Rio de Janeiro

Cardiovascular diseases (CVD) prevail as the main cause of death in developed and developing countries and are among the most frequent causes of disabilities in Brazil and in the world.

Economic alternatives have been studied to assist in reducing cardiovascular risk factors. Within this context, the Solanum menogena, whose fruit known as eggplant is widely consumed in Brazil, is being used in alternative medicine with the purpose to reduce the concentrations of cholesterol, glucose and promote loss of body weight.

Aubergine (eggplant) stands out for its high fibre content (approximately 40%) and low fat content. In addition, it is popularly known for its functional properties, aiding in reducing the risk of coronary diseases. The purplish coloring of the eggplant peel is attributed to the large amount of flavonoids, which have antioxidant properties and contribute to the flavor of eggplant.

The investigators hypothesis is that the eggplant flour associated with a restricted calorie diet has effect in reduction in waist circumference, reduction of body fat and increasing HDL-cholesterol; this way, contributing to the reduction of cardiovascular risk factors

All participants will be informed about the research and they will have to sign a consent form. The volunteers will be divided into two groups: one group will receive a restricted-calorie diet and supplementation with eggplant flour; and the other will receive a diet plus a placebo for 120 days, being both groups evaluated monthly. In each consultation, evaluation of weight, body composition, fulfillment of the diet and blood pressure measurement will be performed. In addition, blood will also be collected in order to determine glucose, insulin, total cholesterol, LDL, HDL, triglycerides, oxidized anti-LDL antibodies, 15-isoprostane and minerals (selenium, zinc, iron, manganese, magnesium and copper). The results will be analyzed by statistical program.

The investigators expect that with the results obtained, the eggplant flour can be used as an ally in the prevention of cardiovascular diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

363

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio de Janeiro
      • São Gonçalo, Rio de Janeiro, Brazil
        • Policlínica de Alcantara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

adults (aged> 20 years) body mass index (BMI)> 25 kg/m2 for both sexes, of any ethnicity.

Exclusion Criteria:

smokers, pregnant women, nursing mothers and that are performing diets and / or using drugs for weight reduction and supplements of any kind.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: eggplant meal
13 g meal of eggplant/day
Dietary supplement: eggplant meal
13 g meal of eggplant/day, being 6,5 g in breakfast and 6,5g in dinner
Placebo Comparator: cassava meal
13 g of placebo/day
Other: cassava meal
13g cassava meal/day,being 6,5 g in breakfast and 6,5g in dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increasing cholesterol- HDL of 10%
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 062/10-CEP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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