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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
History of Changes
  Purpose

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.


Condition Intervention
Inflammation
 Dietary Supplement: tomato ketchup meal
Dietary Supplement: Placebo meal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 6
Study Start Date: November 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462825

Locations
Netherlands
Dept. of Toxicology, Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Director: Aalt Bast, Prof, PhD Maastricht University
  More Information

Publications:

Responsible Party: Antje Weseler, Principal Investigator, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01462825     History of Changes
Other Study ID Numbers: METC11-3-049
Study First Received: September 6, 2011
Last Updated: December 17, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Inflammation
cytokines
chemotaxis
tomatoes
cardiovascular disease

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013