The Effect of Processed Tomato Products on CVD Risks

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Tomato products

• Registration Number: NCT00937742
• Lead Sponsor: Penn State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-09
• Study Completion: 2009-04
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Vascular function	Baseline and end of intervention phase (week 6)
Platelet and monocyte function/activity	Baseline and end of intervention phase (week 6)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States