An interventional study of Tomato and Non-tomato in Inflammation, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-14.
Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Not applicable, Interventional, and Basic science
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.
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Clinical Nutrition Research Center, Illinois Institute of Technology is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Tomato with high carb/fat meal
Other: Tomato
Non-tomato with high carb/fat meal
Other: Non-tomato
Tomato with high carb/fat meal
Also known as: Active Comparator
Non-tomato with high carb/fat meal
Also known as: Placebo Comparator
IL-6 Concentrations
Time frame: 6 hour postprandial study
| Milestone | Tomato First Then Non-tomato | Non-tomato First Then Tomato |
|---|---|---|
| Started | 13 | 12 |
| Completed | 13 | 12 |
| Not completed | 0 | 0 |
| pg/mL | Tomato | Non-tomato |
|---|---|---|
| IL-6 Concentrations | 2.2 ± 0.27 | 2.6 ± 0.28 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tomato | — | 0/25 (0%) | 0/25 (0%) |
| Non-tomato | — | 0/25 (0%) | 0/25 (0%) |
A total of twenty five subjects completed the crossover study (n = 12 females, n = 13 males).
| Age, Continuous(years) | Tomato First Then Non-tomato | Non-tomato First Then Tomato | Total |
|---|---|---|---|
| Mean | 24.9 ± 5 | 28.7 ± 10.7 | 27 ± 8 |
| Sex: Female, Male(Participants) | Tomato First Then Non-tomato | Non-tomato First Then Tomato | Total |
|---|---|---|---|
| Female | 8 | 4 | 12 |
| Male | 5 | 8 | 13 |
Plan to share: Undecided
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Clinical Nutrition Research Center, Illinois Institute of Technology