The Effect of Processed Tomato Products on CVD Risks

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Tomato products


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-tomato products<br>Non-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products | Dietary Supplement: Tomato products<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet and monocyte function/activity |  | Baseline and end of intervention phase (week 6) | 
| Vascular function |  | Baseline and end of intervention phase (week 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipids |  | Baseline and end of intervention phase (week 6) | 
| Insulin/Glucose |  | Baseline and end of intervention phase (week 6) | 
| Inflammatory Markers |  | Baseline and end of intervention phase (week 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, Lycopene, Tomato