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

This study has been completed.
Sponsor:
Collaborator:
Tomato Products Wellness Council
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00937742
First received: July 10, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Cardiovascular Disease
 Dietary Supplement: Tomato products

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Processed Tomatoes on Endothelium- and Platelet- Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Platelet and monocyte function/activity [ Time Frame: Baseline and end of intervention phase (week 6) ] [ Designated as safety issue: No ]
  • Vascular function [ Time Frame: Baseline and end of intervention phase (week 6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipids [ Time Frame: Baseline and end of intervention phase (week 6) ] [ Designated as safety issue: No ]
  • Insulin/Glucose [ Time Frame: Baseline and end of intervention phase (week 6) ] [ Designated as safety issue: No ]
  • Inflammatory Markers [ Time Frame: Baseline and end of intervention phase (week 6) ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937742

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Tomato Products Wellness Council
Investigators
Principal Investigator: Penny M Kris-Etherton, PhD Penn State University
  More Information

No publications provided

Responsible Party: Penn State University, Penny Kris-Etherton
ClinicalTrials.gov Identifier: NCT00937742     History of Changes
Other Study ID Numbers: PKE TOMATO
Study First Received: July 10, 2009
Last Updated: July 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
cardiovascular disease
Lycopene
Tomato

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013