The Effect of Tomato Ketchup on Inflammation
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
tomato ketchup meal
Placebo meal
Sponsored by

About this trial
This is an interventional basic science trial for Inflammation focused on measuring Inflammation, cytokines, chemotaxis, tomatoes, cardiovascular disease
Eligibility Criteria
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
Sites / Locations
- Dept. of Toxicology, Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
tomato ketchup meal
Placebo meal
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Chemotaxis of monocytes ex vivo
Antioxidant plasma concentrations
Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma
Full Information
NCT ID
NCT01462825
First Posted
September 6, 2011
Last Updated
December 17, 2012
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01462825
Brief Title
The Effect of Tomato Ketchup on Inflammation
Official Title
The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Inflammation, cytokines, chemotaxis, tomatoes, cardiovascular disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tomato ketchup meal
Arm Type
Experimental
Arm Title
Placebo meal
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
tomato ketchup meal
Intervention Description
A single intake of 200 g tomato ketchup together with 200 g white cooked rice.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo meal
Intervention Description
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
Primary Outcome Measure Information:
Title
Release of pro-and anti-inflammatory cytokines ex vivo
Description
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)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Chemotaxis of monocytes ex vivo
Time Frame
2 months
Title
Antioxidant plasma concentrations
Description
Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma
Time Frame
2 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aalt Bast, Prof, PhD
Organizational Affiliation
Maastricht University
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Toxicology, Maastricht University Medical Centre
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
20599665
Citation
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.
Results Reference
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PubMed Identifier
21106920
Citation
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.
Results Reference
background
PubMed Identifier
15719372
Citation
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.
Results Reference
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The Effect of Tomato Ketchup on Inflammation
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