The Effect of Processed Tomato Products on CVD Risks (TOMATO)

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Tomato products

Study type: Interventional

Funder types: Other

Identifiers

NCT00937742

PKE TOMATO

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

1. Total cholesterol (TC) is greater than 300 mg/dL;
2. Fasting triglyceride is greater than 300 mg/dL;
3. LDL cholesterol (LDL-C) is greater than 180 mg/dL;
4. Female subjects who are pregnant or lactating;
5. Subjects who are actively losing weight or trying to lose weight;
6. Subjects with known allergy or intolerance to tomato products;
7. 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;
8. 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;
9. subjects with low hematological counts as determined by >or <15% the upper or lower cut-off values of normal established for the lab;
10. Smokers. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Non-tomato products

Experimental group

Description:

Non-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products

Treatment:

Dietary Supplement: Tomato products