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Clinical Trials/NCT00937742
NCT00937742CompletedNot Applicable

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

Penn State University1 site in 1 country32 target enrollmentStarted: January 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Vascular function
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • •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;

Arms & Interventions

Non-tomato products

Experimental

Non-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products

Intervention: Tomato products (Dietary Supplement)

Outcomes

Primary Outcomes

Vascular function

Time Frame: Baseline and end of intervention phase (week 6)

Platelet and monocyte function/activity

Time Frame: Baseline and end of intervention phase (week 6)

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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