TOM: A Study of Tomato Products and Disease Risk
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Tomato Tomato with high carb/fat meal |
Other: Tomato
Tomato with high carb/fat meal
Other Names:
|
| Placebo Comparator: Non-Tomato Non-tomato with high carb/fat meal |
Other: Non-tomato
Non-tomato with high carb/fat meal
Other Names:
|
Outcome Measures
Primary Outcome Measures
- IL-6 Concentrations [6 hour postprandial study]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Nutrition Research Center | Chicago | Illinois | United States | 60616 |
Sponsors and Collaborators
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Tomato Products Wellness Council
Investigators
- Principal Investigator: Britt Burton-Freeman, MS, PhD, Clinical Nutrition Research Center, Illinois Institute of Technology
- Principal Investigator: Indika Edirisinghe, PhD, Clinical Nutrition Research Center, Illinois Institute of Technology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TOM 2009-071
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tomato First Then Non-tomato | Non-tomato First Then Tomato |
|---|---|---|
| Arm/Group Description | Tomato :High fat meal with tomato | Non-tomato :High fat meal with non-tomato |
| Period Title: Overall Study | ||
| STARTED | 13 | 12 |
| COMPLETED | 13 | 12 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Tomato First Then Non-tomato | Non-tomato First Then Tomato | Total |
|---|---|---|---|
| Arm/Group Description | tomato High fat test meal Tomato products: tomato with High fat test meal | Non-tomato high fat test meal Non-tomato test meal: non-tomato with High fat test meal | Total of all reporting groups |
| Overall Participants | 13 | 12 | 25 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
24.9
(5)
|
28.7
(10.7)
|
27
(8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
8
61.5%
|
4
33.3%
|
12
48%
|
| Male |
5
38.5%
|
8
66.7%
|
13
52%
|
Outcome Measures
| Title | IL-6 Concentrations |
|---|---|
| Description | |
| Time Frame | 6 hour postprandial study |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was per-protocol (tomato vs Non-tomato) and no imputations were given for any missing values; missing values treated as a missing. |
| Arm/Group Title | Tomato | Non-tomato |
|---|---|---|
| Arm/Group Description | High fat tomato test meal Tomato products: High fat tomato test meal | Non-tomato high fat test meal Non-tomato test meal: High fat non-tomato test meal |
| Measure Participants | 25 | 25 |
| Least Squares Mean (Standard Error) [pg/mL] |
2.2
(0.27)
|
2.6
(0.28)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tomato, Non-tomato |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Tomato | Non-tomato | ||
| Arm/Group Description | High fat tomato test meal Tomato products: High fat tomato test meal | Non-tomato high fat test meal Non-tomato test meal: High fat non-tomato test meal | ||
All Cause Mortality |
||||
| Tomato | Non-tomato | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Tomato | Non-tomato | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/25 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Tomato | Non-tomato | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/25 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Britt Burton-Freeman |
|---|---|
| Organization | Illinois Institute of Technology |
| Phone | 312-567-5307 |
| bburton@iit.edu |
- TOM 2009-071