A Study of Tomato Products and Disease Risk

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Inflammation

Intervention / Treatment
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* Other: Tomato
* Other: Non-tomato


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tomato<br>Tomato with high carb/fat meal | Other: Tomato<br>* Tomato with high carb/fat meal<br>* Other names: Active Comparator;|
| Placebo Comparator: Non-Tomato<br>Non-tomato with high carb/fat meal | Other: Non-tomato<br>* Non-tomato with high carb/fat meal<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 Concentrations |  | 6 hour postprandial study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tomato, Nutrition