The Effect of Processed Tomato Products on CVD Risks

NCT ID: NCT00937742

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-tomato products

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

Group Type EXPERIMENTAL

Tomato products

Intervention Type DIETARY_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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. -
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tomato Products Wellness Council

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Penny M Kris-Etherton, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Penn State University

University Park, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PKE TOMATO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Recipe for Heart Health
NCT04828447 COMPLETED NA
Diet and Genetic Damage
NCT00340743 COMPLETED