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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Dietary supplement: Tomato products

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-tomato products; Non-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products	Dietary supplement: Tomato products; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Tomato Products Wellness Council
• Investigators: Principal Investigator: Penny M Kris-Etherton, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimated): July 13, 2009

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular disease; Tomato; Lycopene
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PKE TOMATO