NCT00845637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

3 years

First QC Date

February 16, 2009

Last Update Submit

February 20, 2009

Conditions

Dyslipidemia

Keywords

eggplantdyslipidemiapostprandial lipemia

Outcome Measures

Primary Outcomes (1)

  • Lipid profile

    Before treatment and twice on the fouteenth day, before and 2 hours after lipid overload test

Secondary Outcomes (1)

  • Anthropometric measures

    Before treatment and on day fourteen

Study Arms (2)

Eggplant extract

ACTIVE COMPARATOR
Drug: Eggplant extract

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Eggplant extractDRUG

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

Eggplant extract
PlaceboDRUG

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

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetes Mellitus
  • Smoking
  • Use of hypolipidemic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Paulo D Picon, MD, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

March 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2008

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations

BR(1)