ObesityNCT01622309
Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors
A study testing eggplant meal and cassava meal in people with Obesity and Obesity, Abdominal, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obesity, Obesity, Abdominal
- What is being tested?
- eggplant meal and cassava meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Jun 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (aged> 20 years) body mass index (BMI)> 25 kg/m2 for both sexes, of any ethnicity.
Who cannot join
- smokers, pregnant women, nursing mothers and that are performing diets and / or using drugs for weight reduction and supplements of any kind.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Obesity, Obesity, Abdominal
- Being tested
- eggplant meal, cassava meal
- Keywords
- Oxidative Stress, Obesity, Solanum melongena
- Medical subject headings
- Obesity, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eggplant mealDietary supplement
13 g meal of eggplant/day, being 6,5 g in breakfast and 6,5g in dinner
cassava mealOther
13g cassava meal/day,being 6,5 g in breakfast and 6,5g in dinner
| Study group | Role | What they receive |
|---|---|---|
| eggplant meal | Active comparator | 13 g meal of eggplant/day Receives: Dietary Supplement: eggplant meal |
| cassava meal | Placebo comparator | 13 g of placebo/day Receives: Other: cassava meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing cholesterol- HDL of 10%
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Participant, Investigator
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauara Scorsatto, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622309
- Sponsor's protocol ID
- 062/10-CEP
- Status last verified
- Dec 2014
- First submitted
- 13 Jun 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT01622309
- Acronym / sponsor ID
- 062/10-CEP
- Conditions
- Obesity, Obesity, Abdominal
- Keywords
- Oxidative Stress, Obesity, Solanum melongena
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Jun 2012 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eggplant meal | Active comparator | Dietary Supplement: eggplant meal13 g meal of eggplant/day |
| cassava meal | Placebo comparator | Other: cassava meal13 g of placebo/day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults (aged> 20 years) body mass index (BMI)> 25 kg/m2 for both sexes, of any ethnicity.
Key exclusion criteria (1 listed)
- smokers, pregnant women, nursing mothers and that are performing diets and / or using drugs for weight reduction and supplements of any kind.
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 |
|---|---|---|
| eggplant meal13 g meal of eggplant/day, being 6,5 g in breakfast and 6,5g in dinner | Dietary supplement | eggplant meal |
| cassava meal13g cassava meal/day,being 6,5 g in breakfast and 6,5g in dinner | Other | cassava meal |
Primary outcome
Increasing cholesterol- HDL of 10%
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eggplant meal and cassava meal in people with Obesity and Obesity, Abdominal, run by Universidade Federal do Rio de Janeiro 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 2014. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increasing cholesterol- HDL of 10% (time frame: 4 months). 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 3 Dec 2014.