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OpenTrials
Completed

NCT Number: NCT00937742

The Effect of Processed Tomato Products on CVD Risks

The primary working hypothesis is that consuming processed tomatoes frequently/daily will favorably improve endothelium and platelet function disease-risk biomarker profiles in adult men and women compared to consuming no or relatively low amounts of processed tomatoes.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

men and women (>21 <70 years) nonsmokers, with a body mass index (BMI) ranging of 25 to 35 kg/m2, BP < or = 140/90 mmHg

Exclusion criteria

  • Total cholesterol (TC) is greater than 300 mg/dL;
  • Fasting triglyceride is greater than 300 mg/dL;
  • LDL cholesterol (LDL-C) is greater than 180 mg/dL;
  • Female subjects who are pregnant or lactating;
  • Subjects who are actively losing weight or trying to lose weight;
  • Subjects with known allergy or intolerance to tomato products;
  • taking any medications that would interfere with outcomes of the study, ie. lipid lowering medications, anti-inflammatory drugs, dietary supplements, such as fish oil or evening primrose;
  • subjects' with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (>=140/90 mm Hg - ok if controlled below this limit with medication), or other systemic diseases;
  • subjects with low hematological counts as determined by >or <15% the upper or lower cut-off values of normal established for the lab;
  • Smokers. -

Treatment and study plan

Tomato products

Dietary Supplement

Specified amounts of tomato products (i.e. tomato juice, ketchup, salsa, tomato soup, spaghetti sauce) to be consumed daily during a 6 week intervention phase.

Primary outcomes

  1. Platelet and monocyte function/activity

    Time frame: Baseline and end of intervention phase (week 6)

  2. Vascular function

    Time frame: Baseline and end of intervention phase (week 6)

Secondary outcomes

  1. Lipids

    Time frame: Baseline and end of intervention phase (week 6)

  2. Insulin/Glucose

    Time frame: Baseline and end of intervention phase (week 6)

  3. Inflammatory Markers

    Time frame: Baseline and end of intervention phase (week 6)

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Tomato Products Wellness Council

Registry information

Official study title

The Effect of Processed Tomatoes on Endothelium- and Platelet- Function

Acronym: TOMATO

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jul 13, 2009
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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