Status:
COMPLETED
The Effect of Processed Tomato Products on CVD Risks
Lead Sponsor:
Penn State University
Collaborating Sponsors:
Tomato Products Wellness Council
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
21-70 years
Phase:
NA
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 com...
Eligibility Criteria
Inclusion
- 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
- 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. -
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00937742
Start Date
January 1 2008
End Date
April 1 2009
Last Update
August 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State University
University Park, Pennsylvania, United States, 16802