A Study of Tomato Products and Disease Risk (TOM)
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 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|
- 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 ]
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966550
|United States, Illinois|
|Clinical Nutrition Research Center|
|Chicago, Illinois, United States, 60616|
|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|