The Effect of Tomato Ketchup on Inflammation

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462825
• Other study ID #: METC11-3-049
• Status: Completed
• Phase: N/A
• First received: September 6, 2011
• Last updated: December 17, 2012
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• tomato ketchup meal
A single intake of 200 g tomato ketchup together with 200 g white cooked rice.
• 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

Locations

Country	Name	City	State
Netherlands	Dept. of Toxicology, Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Chemotaxis of monocytes ex vivo		2 months	No
Secondary	Antioxidant plasma concentrations	Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma	2 months	No