Effect of Eggplant Extract on Lipid Profile During Fasting and Postprandial Period

NCT ID: NCT00845637

Last Updated: 2009-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2008-03-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Eggplant extract

Group Type: ACTIVE_COMPARATOR

Eggplant extract

Intervention Type: DRUG

Dry eggplant extract in two 450mg capsules, twice a day (before the main meals) for fourteen days.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo in two 450mg capsules, twice a day (before the main meals) for fourteen days.

Interventions

Eggplant extract

Dry eggplant extract in two 450mg capsules, twice a day (before the main meals) for fourteen days.

Intervention Type: DRUG

Placebo

Placebo in two 450mg capsules, twice a day (before the main meals) for fourteen days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Baseline clinical evaluation conducted by a doctor
• Informed consent form

Exclusion Criteria

• Diabetes Mellitus
• Smoking
• Use of hypolipidemic medication

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Hospital de Clínicas de Porto Alegre

Principal Investigators

Paulo D Picon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

04004

Identifier Type: -

Identifier Source: org_study_id