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Tomato Consumption and High Density Lipoprotein-cholesterol

NCT01342666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-02-28

Study results available
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Summary

* This is a randomized, open-label, single blind, clinical trial
* The study evaluated the effect of tomato consumption in serum HDL-cholesterol levels.
* The hypothesis was that two daily tomatoes during one month will increase the HDL-c levels.
* Since a placebo of tomatoes cannot be done, the control group will receive same proportion of cucumber because 1) it was not possible to have a tomato placebo; 2) cucumber does not have any lycopene; 3) both can be prepared similarly; and 4) the required quantity can be measured in the same way.
* The intervention was during 1 month and was assigned by randomization.
* Personnel who did the clinical and biochemical evaluation were blinded for the intervention.
* Lipid profile was measured before and after the intervention.
* Confounding factors such as daily physical activity, diet, consumption of fish or alcoholic beverages, smoking status were considered during statistical analyses.

Conditions

  • Hypoalphalipoproteinemia

Interventions

DIETARY_SUPPLEMENT

Tomato consumption

Daily consumption of 300g of uncooked roma tomatoes during one month.

DIETARY_SUPPLEMENT

Cucumber consumption

Daily consumption of 300g of cucumber.

Sponsors & Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez

    collaborator OTHER

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Francisco J Gomez-Perez, MD, FACE · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-04-30
Completion
2011-12-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01342666 on ClinicalTrials.gov