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.

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Dietary supplement: tomato ketchup meal; Dietary supplement: Placebo 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Dept. of Toxicology, Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• 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: November 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: September 6, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (ESTIMATE): October 31, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2012
• Last Update Submitted That Met QC Criteria: December 17, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Inflammation; cardiovascular disease; cytokines; chemotaxis; tomatoes
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: METC11-3-049