The Effect of Tomato Ketchup on Inflammation

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01462825

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

6.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation	Dietary Supplement: tomato ketchup meal Dietary Supplement: Placebo meal	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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