Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors
Primary Purpose
Obesity, Obesity, Abdominal
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
eggplant meal
cassava meal
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Oxidative Stress, Obesity, Solanum melongena
Eligibility Criteria
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.
Sites / Locations
- Policlínica de Alcantara
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
eggplant meal
cassava meal
Arm Description
13 g meal of eggplant/day
13 g of placebo/day
Outcomes
Primary Outcome Measures
Increasing cholesterol- HDL of 10%
Secondary Outcome Measures
Full Information
NCT ID
NCT01622309
First Posted
June 13, 2012
Last Updated
December 2, 2014
Sponsor
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT01622309
Brief Title
Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors
Official Title
Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity, Abdominal
Keywords
Oxidative Stress, Obesity, Solanum melongena
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
363 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eggplant meal
Arm Type
Active Comparator
Arm Description
13 g meal of eggplant/day
Arm Title
cassava meal
Arm Type
Placebo Comparator
Arm Description
13 g of placebo/day
Intervention Type
Dietary Supplement
Intervention Name(s)
eggplant meal
Intervention Description
13 g meal of eggplant/day, being 6,5 g in breakfast and 6,5g in dinner
Intervention Type
Other
Intervention Name(s)
cassava meal
Intervention Description
13g cassava meal/day,being 6,5 g in breakfast and 6,5g in dinner
Primary Outcome Measure Information:
Title
Increasing cholesterol- HDL of 10%
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Policlínica de Alcantara
City
São Gonçalo
State/Province
Rio de Janeiro
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors
We'll reach out to this number within 24 hrs