The Effect of Tomato Ketchup on Inflammation

Not Applicable

Completed

• Conditions: Inflammation

• Registration Number: NCT01462825
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-31
• Study Start: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-17
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Release of pro-and anti-inflammatory cytokines ex vivo	2 months	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

Name	Time	Method
Chemotaxis of monocytes ex vivo	2 months
Antioxidant plasma concentrations	2 months	Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma

Trial Locations

Locations (1)

Dept. of Toxicology, Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands