- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01462825
The Effect of Tomato Ketchup on Inflammation
The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Maastricht, Netherlands
- Dept. of Toxicology, Maastricht University Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: tomato ketchup meal
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A single intake of 200 g tomato ketchup together with 200 g white cooked rice.
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PLACEBO_COMPARATOR: Placebo meal
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Release of pro-and anti-inflammatory cytokines ex vivo
Time Frame: 2 months
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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)
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chemotaxis of monocytes ex vivo
Time Frame: 2 months
|
2 months
|
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Antioxidant plasma concentrations
Time Frame: 2 months
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Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma
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2 months
|
Collaborators and Investigators
Investigators
- Study Director: Aalt Bast, Prof, PhD, Maastricht University
Publications and helpful links
General Publications
- Palozza P, Parrone N, Simone RE, Catalano A. Lycopene in atherosclerosis prevention: an integrated scheme of the potential mechanisms of action from cell culture studies. Arch Biochem Biophys. 2010 Dec 1;504(1):26-33. doi: 10.1016/j.abb.2010.06.031. Epub 2010 Jul 3.
- Mateo Anson N, Aura AM, Selinheimo E, Mattila I, Poutanen K, van den Berg R, Havenaar R, Bast A, Haenen GR. Bioprocessing of wheat bran in whole wheat bread increases the bioavailability of phenolic acids in men and exerts antiinflammatory effects ex vivo. J Nutr. 2011 Jan;141(1):137-43. doi: 10.3945/jn.110.127720. Epub 2010 Nov 24.
- Swennen EL, Bast A, Dagnelie PC. Immunoregulatory effects of adenosine 5'-triphosphate on cytokine release from stimulated whole blood. Eur J Immunol. 2005 Mar;35(3):852-8. doi: 10.1002/eji.200425423.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC11-3-049
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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