Clinical trial NCT01462825: The Effect of Tomato Ketchup on Inflammation
Official title: The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Inflammation
cytokines
chemotaxis
tomatoes
cardiovascular disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-10-31
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Release of pro-and anti-inflammatory cytokines ex vivo
timeFrame: 2 months
Secondary outcomes:
measure: Chemotaxis of monocytes ex vivo
timeFrame: 2 months
measure: Antioxidant plasma concentrations
timeFrame: 2 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Dept. of Toxicology, Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University
name: Aalt Bast, Prof, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.