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

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Eggplant extract; Drug: Placebo

• Registration Number: NCT00845637
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2007-03
• Study Completion: 2008-03
• Status Verified: 2009-02
• Study First Submitted: 2009-02-16
• Study First Submitted QC: 2009-02-16
• Study First Posted: 2009-02-18
• Last Update Submitted: 2009-02-20
• Last Update Posted: 2009-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

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

Exclusion Criteria

• Diabetes Mellitus
• Smoking
• Use of hypolipidemic medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eggplant extract	Eggplant extract	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Lipid profile	Before treatment and twice on the fouteenth day, before and 2 hours after lipid overload test

Secondary Outcome Measures

Name	Time	Method
Anthropometric measures	Before treatment and on day fourteen

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil