N/A
Completed N=25
A Study of Tomato Products and Disease Risk
Source: ClinicalTrials.gov NCT00966550 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: IL-6 Concentrations — 2.2; 2.6 pg/mL — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IL-6 Concentrations |
2.2; 2.6 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Male and female
- Between ages of 18-65
- BMI between 19 and 24 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)
Data sourced from ClinicalTrials.gov (NCT00966550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.