A Study of Tomato Products and Disease Risk (TOM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tomato Wellness Council California
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier:
NCT00966550
First received: August 26, 2009
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Inflammation
Other: Tomato products
Other: Non-tomato test meal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Tomato Products and Postprandial Oxidation and Inflammation: a Clinical Trial in Healthy Weight Men and Women

Resource links provided by NLM:


Further study details as provided by Institute for Food Safety and Health, United States:

Primary Outcome Measures:
  • The ability of tomato products to modify postprandial inflammation in healthy weight individuals in an acute postprandial paradigm. [ Time Frame: 6 hour postprandial study ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: August 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tomato
High fat tomato test meal
Other: Tomato products
High fat tomato test meal
Other Name: Nutrition
Active Comparator: Non-tomato
Non-tomato high fat test meal
Other: Non-tomato test meal
High fat non-tomato test meal
Other Name: Nutriton

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. We 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 your 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 this screening visit, other than transportation costs.

If you qualify, you will continue to the two study visits. Each visit will require you to have blood drawn several times during your 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 your vein for ease in drawing blood. After the catheter placement and the first blood draw, you will be asked to eat the test meal (tomato or non-tomato meal) and then you will continue to have blood taken at specific time points for the next 6 hours. We will also do an ultrasound on your arm to measure blood flow both before eating and midway through the 6 - hour study visit. We will ask that you not consume tomatoes or tomato products during the course of the study and record all food and beverages consumed on certain days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966550

Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
Tomato Wellness Council California
Investigators
Principal Investigator: Britt Burton-Freeman, MS, PhD Institute for Food Safety and Health, United States
Principal Investigator: Indika Edirisinghe, PhD Institute for Food Safety and Health, United States
  More Information

No publications provided by Institute for Food Safety and Health, United States

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT00966550     History of Changes
Other Study ID Numbers: TOM 2009-071
Study First Received: August 26, 2009
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Food Safety and Health, United States:
Tomato
Nutrition

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014