The Effect of Processed Tomato Products on CVD Risks
TOMATO
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedAugust 21, 2023
August 1, 2023
8 months
July 10, 2009
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Platelet and monocyte function/activity
Baseline and end of intervention phase (week 6)
Vascular function
Baseline and end of intervention phase (week 6)
Secondary Outcomes (3)
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)
Study Arms (1)
Non-tomato products
EXPERIMENTALNon-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Total cholesterol (TC) is greater than 300 mg/dL;
- Fasting triglyceride is greater than 300 mg/dL;
- LDL cholesterol (LDL-C) is greater than 180 mg/dL;
- Female subjects who are pregnant or lactating;
- Subjects who are actively losing weight or trying to lose weight;
- Subjects with known allergy or intolerance to tomato products;
- 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;
- 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;
- subjects with low hematological counts as determined by \>or \<15% the upper or lower cut-off values of normal established for the lab;
- Smokers. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penn State Universitylead
- Tomato Products Wellness Councilcollaborator
Study Sites (1)
Penn State University
University Park, Pennsylvania, 16802, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Penny M Kris-Etherton, PhD
Penn State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2009
First Posted
July 13, 2009
Study Start
January 1, 2008
Primary Completion
September 1, 2008
Study Completion
April 1, 2009
Last Updated
August 21, 2023
Record last verified: 2023-08