The Effect of Processed Tomato Products on CVD Risks | NCT00937742

Studies
The Effect of Processed Tomato Products on CVD Risks

NCT00937742

Sponsor

Penn State University

Status

Completed

Last Update Posted

Aug 21, 2023Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Cardiovascular Disease

Interventions

Tomato products

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Apr 2009Actual

First Submitted Date

Jul 10, 2009

First Submission Date that Met QC Criteria

Jul 10, 2009

First Posted Date

Jul 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2023

Last Update Posted Date

Aug 21, 2023Actual

Name	Class
Tomato Products Wellness Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-tomato products	Experimental	Non-tomato products (i.e. teriyaki marinade, sprite, applesauce) to be consumed daily in replace of tomato products	Dietary Supplement: Tomato products

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tomato products	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.

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Lipids		Baseline and end of intervention phase (week 6)
Insulin/Glucose		Baseline and end of intervention phase (week 6)
Inflammatory Markers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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;
Smokers. -

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Penny M Kris-Etherton, PhD	Penn State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn State University		University Park	Pennsylvania	16802	United States