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OpenTrials
Completed

NCT Number: NCT01622309

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlínica de Alcantara

São Gonçalo, Rio de Janeiro, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eggplant meal

Dietary Supplement

13 g meal of eggplant/day, being 6,5 g in breakfast and 6,5g in dinner

cassava meal

Other

13g cassava meal/day,being 6,5 g in breakfast and 6,5g in dinner

Primary outcomes

  1. Increasing cholesterol- HDL of 10%

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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