Completed

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

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What is being tested

Eggplant extract

+ Placebo

Drug
Who is being recruted

Metabolic Diseases+1

+ Nutritional and Metabolic Diseases

+ Dyslipidemias

+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorHospital de Clinicas de Porto Alegre
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleEffect of the Oral Administration of Eggplant Extract Capsules on Lipid Profile During Fasting and Postprandial Period: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Principal SponsorHospital de Clinicas de Porto Alegre
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Metabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism Disorders

Criteria

2 inclusion criteria required to participate
Baseline clinical evaluation conducted by a doctor

Informed consent form

3 exclusion criteria prevent from participating
Diabetes Mellitus

Smoking

Use of hypolipidemic medication

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital de Clínicas de Porto Alegre

Porto Alegre, BrazilOpen Hospital de Clínicas de Porto Alegre in Google Maps
CompletedOne Study Center