Cardiovascular DiseaseTOMATONCT00937742
The Effect of Processed Tomato Products on CVD Risks
A study testing Tomato products in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Tomato products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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. -
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Tomato products
- Keywords
- cardiovascular disease, Lycopene, Tomato
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomato productsDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-tomato products | Experimental | Non-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products Receives: Dietary Supplement: Tomato products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet and monocyte function/activity
Measured: Baseline and end of intervention phase (week 6)
Vascular function
Measured: Baseline and end of intervention phase (week 6)
Secondary outcomes (3)
Lipids
Measured: Baseline and end of intervention phase (week 6)
Insulin/Glucose
Measured: Baseline and end of intervention phase (week 6)
Inflammatory Markers
Measured: Baseline and end of intervention phase (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Tomato Products Wellness Council
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937742
- Sponsor's protocol ID
- PKE TOMATO
- Acronym
- TOMATO
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2009
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Processed Tomatoes on Endothelium- and Platelet- Function
- ClinicalTrials.gov ID
- NCT00937742
- Acronym / sponsor ID
- TOMATO / PKE TOMATO
- Conditions
- Cardiovascular Disease
- Keywords
- cardiovascular disease, Lycopene, Tomato
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Tomato Products Wellness Council
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-tomato products | Experimental | Dietary Supplement: Tomato productsNon-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomato productsSpecified amounts of tomato products (i.e. tomato juice, ketchup, salsa, tomato soup, spaghetti sauce) to be consumed daily during a 6 week intervention phase. | Dietary supplement | Non-tomato products |
Primary outcome
Platelet and monocyte function/activity
Time frame: Baseline and end of intervention phase (week 6)
Vascular function
Time frame: Baseline and end of intervention phase (week 6)
3 secondary outcomes
Lipids
Time frame: Baseline and end of intervention phase (week 6)
Insulin/Glucose
Time frame: Baseline and end of intervention phase (week 6)
Inflammatory Markers
Time frame: Baseline and end of intervention phase (week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny M Kris-Etherton, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomato products in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet and monocyte function/activity (time frame: Baseline and end of intervention phase (week 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.