A Study of Tomato Products and Disease Risk (TOM)

February 3, 2017 updated by: Clinical Nutrition Research Center, Illinois Institute of Technology

Tomato Products and Postprandial Oxidation and Inflammation: a Clinical Trial in Healthy Weight Men and Women

The purpose of this research study is to test whether certain compounds in tomatoes will help reduce factors in the subject's blood associated with disease risk. The investigators want to know if the tomato-associated compounds will lower or improve the status of these factors, like cholesterol and inflammation. In this research study, the subject will be asked to consume high fat test meals on two separate occasions. The investigators want to see how the subject's body responds to a standard high fat meal, one meal with tomato products and one meal without tomato products. The investigators will measure the subject's blood throughout the study period to determine if consumption of tomato products reduces factors in their blood associated with disease risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will take three weeks at most, and require one initial screening visit lasting approximately 45 minutes and two study visits each lasting approximately 6 - 8 hours. The investigators are looking for healthy, non-smoking male and female volunteers between the ages of 18 - 65, with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.

The initial screening visit will determine subject' eligibility through height, weight and waist circumference measurements, blood glucose (finger prick) test and a fasting screening blood draw. There will be no compensation for the screening visit, other than transportation costs.

If subject qualify, subject will continue to the two study visits. Each visit will require subject to have blood drawn several times during subject' study visit (total amount of blood equal to approximately 1 ½ tablespoons). To make this process more tolerable, a registered nurse will place a catheter (similar to what happens when you give blood) into subject's vein for ease in drawing blood. After the catheter placement and the first blood draw, subject will be asked to eat the test meal (tomato or non-tomato meal) and then subject will continue to have blood taken at specific time points for the next 6 hours. The investigators will also do an ultrasound on subject's arm to measure blood flow both before eating and midway through the 6 - hour study visit. The investigators will ask that subject not consume tomatoes or tomato products during the course of the study and record all food and beverages consumed on certain days.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Clinical Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female
  • Between ages of 18-65
  • BMI between 19 and 24 and hsCRP < 1mg/L
  • BMI between 25 and 35 and hsCRP > 2.5mg/L
  • No clinical evidence of cardiovascular, respiratory, renal, GI or hepatic disease

Exclusion Criteria:

  • Pregnant and/or lactating
  • allergies or intolerances to foods consumed in the study
  • fasting blood glucose > 110mg/dL
  • taking OTC antioxidant supplements, prescription meds that may interfere with study endpoints
  • unusual dietary habits
  • actively trying to lose or gain weight
  • addicted to drugs or alcohol
  • medically documented psychiatric or neurological disturbances
  • smoker (past smoker allowed if cessation > 2 years)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tomato
Tomato with high carb/fat meal
Other: Tomato
Tomato with high carb/fat meal
Other Names:
  • Active Comparator
PLACEBO_COMPARATOR: Non-Tomato
Non-tomato with high carb/fat meal
Other: Non-tomato
Non-tomato with high carb/fat meal
Other Names:
  • Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IL-6 Concentrations
Time Frame: 6 hour postprandial study
6 hour postprandial study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Collaborators

Tomato Products Wellness Council

Investigators

  • Principal Investigator: Britt Burton-Freeman, MS, PhD, Clinical Nutrition Research Center, Illinois Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (ESTIMATE)

August 27, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOM 2009-071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Tomato

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe