The Effect of Tomato Ketchup on Inflammation

Study Overview
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Brief Summary
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The purpose of this study is to determine the inhibiting effects of a single consumption of tomato ketchup on inflammation which will be induced ex-vivo in human blood.

Detailed Description
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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.

Official Title
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The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood

Conditions
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Inflammation

Intervention / Treatment
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* Dietary Supplement: tomato ketchup meal
* Dietary Supplement: Placebo meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≤ 30 kg/m2 Age >18 years Exclusion Criteria: Occurence of any adverse event, in particular those which require the use of medication that might interfere with the effects and/or the uptake of the investigational products Intolerance of study products Occurence of a serious adverse event Use of supplements, functional foods and/or other products containing tomatoes, vitamins, antioxidants and polyphenolic compounds Use of a medically prescribed diet or slimming diet Vegetarian or vegan lifestyle Excessive alcohol consumption (< 28 consumptions (approximately 250 g alcohol) per week) Participation in a clinical trial within 4 weeks before the study Non-compliance with the demands of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tomato ketchup meal<br> | Dietary Supplement: tomato ketchup meal<br>* A single intake of 200 g tomato ketchup together with 200 g white cooked rice.<br>|
| Placebo Comparator: Placebo meal<br> | Dietary Supplement: Placebo meal<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Release of pro-and anti-inflammatory cytokines ex vivo | 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) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotaxis of monocytes ex vivo |  | 2 months | 
| Antioxidant plasma concentrations | Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, cytokines, chemotaxis, tomatoes, cardiovascular disease