DyslipidemiaPhase 1NCT00845637
Effect of Eggplant Extract on Lipid Profile During Fasting and Postprandial Period
A Phase 1 study testing Eggplant extract in people with Dyslipidemia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study was to assess the effect of eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test in a randomized, double-blind, placebo-controlled clinical trial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Eggplant extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2004to Mar 2008
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Baseline clinical evaluation conducted by a doctor
- Informed consent form
Who cannot join
- Diabetes Mellitus
- Smoking
- Use of hypolipidemic medication
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Effect of the Oral Administration of Eggplant Extract Capsules on Lipid Profile During Fasting and Postprandial Period: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
The purpose of this study was to assess the effect of eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test in a randomized, double-blind, placebo-controlled clinical trial.
Read the detailed description
Dry eggplant extract(Solanum melongena) has been used by the population as an alternative treatment for dyslipidemia. It is a vegetable rich in flavonoids, which are polyphenol anti-oxidants found in foods. Studies suggest an inverse relationship between the ingestion of foods rich in flavonoids and mortality from coronary artery disease. The aim of this study was to assess the effect of administering eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test.
Participants underwent a baseline clinical evaluation conducted by a doctor, who assessed whether the volunteer was apt to participate in the study. Diabetics, smokers and users of hypolipidemic medication were excluded. After signing an informed consent form, 59 healthy volunteers of both genders were randomized to take either capsules containing 450 mg of dry eggplant extract or placebo. Both interventions were administered in quantities of two capsules, twice a day, for 14 days, and both patient and doctor were unaware of the drug in use.
The main outcome measure was lipid profile, which was checked during fasting on days 0 and 14, and also during postprandial period on the 14th day, when participants underwent a lipid overload test immediately after ingesting 900 mg of eggplant extract or placebo, as per prior randomization. The nutritional analysis of the meal contained 361 kcal and 22.5g of total fat, 14.5 g of which was saturated and 251mg of cholesterol. Laboratory exams were taken (total cholesterol, triglycerides, HDL-C). LDL-C was calculated according to the Friedewald formula: LDL-C = CT - HDL-C - TG/5. The nutritional value of food records was conducted with the help of Diet Win for Windows nutritional evaluation software.
Anthropometric evaluation was also performed, including body weight, height and abdominal circumference, at baseline and on day 14, by the same investigator, blinded to the intervention.
- Conditions
- Dyslipidemia
- Being tested
- Eggplant extract, Placebo
- Keywords
- eggplant, dyslipidemia, postprandial lipemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eggplant extractDrug
Dry eggplant extract in two 450mg capsules, twice a day (before the main meals) for fourteen days.
PlaceboDrug
Placebo in two 450mg capsules, twice a day (before the main meals) for fourteen days.
| Study group | Role | What they receive |
|---|---|---|
| Eggplant extract | Active comparator | Not described Receives: Drug: Eggplant extract |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Measured: Before treatment and twice on the fouteenth day, before and 2 hours after lipid overload test
Secondary outcomes (1)
Anthropometric measures
Measured: Before treatment and on day fourteen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startMar 2004
- Primary completionMar 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Paulo D Picon, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845637
- Sponsor's protocol ID
- 04004
- Status last verified
- Feb 2009
- First submitted
- 16 Feb 2009
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Oral Administration of Eggplant Extract Capsules on Lipid Profile During Fasting and Postprandial Period: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00845637
- Acronym / sponsor ID
- 04004
- Conditions
- Dyslipidemia
- Keywords
- eggplant, dyslipidemia, postprandial lipemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 18 Feb 2009 (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.
The purpose of this study was to assess the effect of eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test in a randomized, double-blind, placebo-controlled clinical trial.
Detailed description
Dry eggplant extract(Solanum melongena) has been used by the population as an alternative treatment for dyslipidemia. It is a vegetable rich in flavonoids, which are polyphenol anti-oxidants found in foods. Studies suggest an inverse relationship between the ingestion of foods rich in flavonoids and mortality from coronary artery disease. The aim of this study was to assess the effect of administering eggplant extract capsules on the lipid profile of healthy individuals after an oral lipid overload test.
Participants underwent a baseline clinical evaluation conducted by a doctor, who assessed whether the volunteer was apt to participate in the study. Diabetics, smokers and users of hypolipidemic medication were excluded. After signing an informed consent form, 59 healthy volunteers of both genders were randomized to take either capsules containing 450 mg of dry eggplant extract or placebo. Both interventions were administered in quantities of two capsules, twice a day, for 14 days, and both patient and doctor were unaware of the drug in use.
The main outcome measure was lipid profile, which was checked during fasting on days 0 and 14, and also during postprandial period on the 14th day, when participants underwent a lipid overload test immediately after ingesting 900 mg of eggplant extract or placebo, as per prior randomization. The nutritional analysis of the meal contained 361 kcal and 22.5g of total fat, 14.5 g of which was saturated and 251mg of cholesterol. Laboratory exams were taken (total cholesterol, triglycerides, HDL-C). LDL-C was calculated according to the Friedewald formula: LDL-C = CT - HDL-C - TG/5. The nutritional value of food records was conducted with the help of Diet Win for Windows nutritional evaluation software.
Anthropometric evaluation was also performed, including body weight, height and abdominal circumference, at baseline and on day 14, by the same investigator, blinded to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eggplant extract | Active comparator | Drug: Eggplant extract |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Baseline clinical evaluation conducted by a doctor
- Informed consent form
Key exclusion criteria (3 listed)
- Diabetes Mellitus
- Smoking
- Use of hypolipidemic medication
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 extractDry eggplant extract in two 450mg capsules, twice a day (before the main meals) for fourteen days. | Drug | Eggplant extract |
| PlaceboPlacebo in two 450mg capsules, twice a day (before the main meals) for fourteen days. | Drug | Placebo |
Primary outcome
Lipid profile
Time frame: Before treatment and twice on the fouteenth day, before and 2 hours after lipid overload test
1 secondary outcome
Anthropometric measures
Time frame: Before treatment and on day fourteen
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 24 Feb 2009.
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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.
Paulo D Picon, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eggplant extract in people with Dyslipidemia, run by Hospital de Clinicas de Porto Alegre 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 2 inclusion and 3 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 24 Feb 2009. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lipid profile (time frame: Before treatment and twice on the fouteenth day, before and 2 hours after lipid overload test). 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 24 Feb 2009; AzTrials last refreshed its copy on 7 Nov 2026.