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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014