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

Sponsor
Universidade Federal do Rio de Janeiro (Other)
Overall Status
Completed
CT.gov ID
NCT01622309
Collaborator
(none)
363
1
2
15
24.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: eggplant meal
  • Other: cassava meal
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
363 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Increasing cholesterol- HDL of 10% [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Policlínica de Alcantara São Gonçalo Rio de Janeiro Brazil

Sponsors and Collaborators

  • Universidade Federal do Rio de Janeiro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mauara Scorsatto, Doctoral student, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01622309
Other Study ID Numbers:
  • 062/10-CEP
First Posted:
Jun 19, 2012
Last Update Posted:
Dec 3, 2014
Last Verified:
Dec 1, 2014
Keywords provided by Mauara Scorsatto, Doctoral student, Universidade Federal do Rio de Janeiro
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2014