The Effect of Tomato Ketchup on Inflammation
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|ClinicalTrials.gov Identifier: NCT01462825|
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : December 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Dietary Supplement: tomato ketchup meal Dietary Supplement: Placebo meal||Not Applicable|
The consumption of tomatoes and tomato products has been associated with a lower risk of developing cardiovascular disease and some types of cancer. Tomatoes and tomato products provide a good source of antioxidants (lipophilic and hydrophilic). The major tomato antioxidants comprise lycopene, α-tocopherol and ascorbic acid. It has been reported that these antioxidants in isolated form exert directly or indirectly anti-inflammatory effects in vitro. Studies with tomatoes or tomato products revealed that the observed anti-inflammatory effects could not be caused by the presence of only one antioxidant. It was suggested that these effects were due to the combination of antioxidants.
In recent cell culture studies with human endothelial cells we have shown that tomato ketchup exerts significant anti-inflammatory effects, which could be related to the particular composition of antioxidants, i.e. lycopene, ascorbic acid and α-tocopherol. Since, however, the relevance of the observed anti-inflammatory effects for humans is entirely unknown, the present pilot study aims to assess the acute effects of a single tomato ketchup consumption on ex vivo elicited inflammation in a small group of healthy volunteers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2011|
|Experimental: tomato ketchup meal||
Dietary Supplement: tomato ketchup meal
A single intake of 200 g tomato ketchup together with 200 g white cooked rice.
|Placebo Comparator: Placebo meal||
Dietary Supplement: Placebo meal
Self-prepared vinaigrette matching the qualitative and quantitative macronutrient composition of the tomato ketchup together with 200 g cooked rice resulting in a meal that is isocaloric to the tomato-ketchup meal
- Release of pro-and anti-inflammatory cytokines ex vivo [ Time Frame: 2 months ]6h after consumption of tomato ketchup blood will be collected and challenged ex vivo with bacterial endotoxin (LPS) in order to elicit the release of pro- (TNF-alpha, IL-8) and anti-inflammatory cytokines (IL-10)
- Chemotaxis of monocytes ex vivo [ Time Frame: 2 months ]
- Antioxidant plasma concentrations [ Time Frame: 2 months ]Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462825
|Dept. of Toxicology, Maastricht University Medical Centre|
|Study Director:||Aalt Bast, Prof, PhD||Maastricht University|