Inflammation
Conditions
Keywords
Tomato, Nutrition
Brief summary
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
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.
Interventions
OTHERTomato
Tomato with high carb/fat meal
OTHERNon-tomato
Non-tomato with high carb/fat meal
Sponsors
Tomato Products Wellness Council
Clinical Nutrition Research Center, Illinois Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IL-6 Concentrations | 6 hour postprandial study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tomato First Then Non-tomato tomato High fat test meal
Tomato products: tomato with High fat test meal | 13 |
| Non-tomato First Then Tomato Non-tomato high fat test meal
Non-tomato test meal: non-tomato with High fat test meal | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Tomato First Then Non-tomato | Non-tomato First Then Tomato | Total |
|---|---|---|---|
| Age, Continuous | 24.9 years STANDARD_DEVIATION 5 | 28.7 years STANDARD_DEVIATION 10.7 | 27 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
IL-6 Concentrations
Time frame: 6 hour postprandial study
Population: Analysis was per-protocol (tomato vs Non-tomato) and no imputations were given for any missing values; missing values treated as a missing.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tomato | IL-6 Concentrations | 2.2 pg/mL | Standard Error 0.27 |
| Non-tomato | IL-6 Concentrations | 2.6 pg/mL | Standard Error 0.28 |
p-value: <0.0001Mixed Models Analysis