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

July 10, 2009
July 10, 2009
January 2008
September 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Processed Tomato Products on CVD Risks
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiovascular Disease
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.
Experimental: Non-tomato products
Non-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products
Intervention: Dietary Supplement: Tomato products
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2009
September 2008   (final data collection date for primary outcome measure)

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. -
Both
21 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00937742
PKE TOMATO
No
Penn State University, Penny Kris-Etherton
Penn State University
Tomato Products Wellness Council
Principal Investigator: Penny M Kris-Etherton, PhD Penn State University
Penn State University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP