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The Effect of Tomato Ketchup on Inflammation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antje Weseler, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01462825
First received: September 6, 2011
Last updated: December 17, 2012
Last verified: December 2012

September 6, 2011
December 17, 2012
November 2011
November 2011   (final data collection date for primary outcome measure)
Release of pro-and anti-inflammatory cytokines ex vivo [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01462825 on ClinicalTrials.gov Archive Site
  • Chemotaxis of monocytes ex vivo [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Antioxidant plasma concentrations [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma
Same as current
Not Provided
Not Provided
 
The Effect of Tomato Ketchup on Inflammation
The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Inflammation
  • Dietary Supplement: tomato ketchup meal
    A single intake of 200 g tomato ketchup together with 200 g white cooked rice.
  • 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
  • Experimental: tomato ketchup meal
    Intervention: Dietary Supplement: tomato ketchup meal
  • Placebo Comparator: Placebo meal
    Intervention: Dietary Supplement: Placebo meal

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01462825
METC11-3-049
No
Antje Weseler, Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Study Director: Aalt Bast, Prof, PhD Maastricht University
Maastricht University Medical Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP