The Effect of Processed Tomato Products on CVD Risks

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00937742

Acronym

TOMATO

Enrollment

Registered

2009-07-13

Start date

2008-01-31

Completion date

2009-04-30

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

cardiovascular disease, Lycopene, Tomato

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.

Interventions

DIETARY_SUPPLEMENTTomato 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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

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. -

Design outcomes

Primary

Measure	Time frame
Platelet and monocyte function/activity	Baseline and end of intervention phase (week 6)
Vascular function	Baseline and end of intervention phase (week 6)

Secondary

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026