The Effect of Processed Tomato Products on CVD Risks

Cardiovascular Disease Clinical Trial

— TOMATO  

Official title:

The Effect of Processed Tomatoes on Endothelium- and Platelet- Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937742
• Other study ID #: PKE TOMATO
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Tomato Products Wellness Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet and monocyte function/activity		Baseline and end of intervention phase (week 6)
Primary	Vascular function		Baseline and end of intervention phase (week 6)
Secondary	Lipids		Baseline and end of intervention phase (week 6)
Secondary	Insulin/Glucose		Baseline and end of intervention phase (week 6)
Secondary	Inflammatory Markers		Baseline and end of intervention phase (week 6)