NCT01462825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

Same day

First QC Date

September 6, 2011

Last Update Submit

December 17, 2012

Conditions

Inflammation

Keywords

Inflammationcytokineschemotaxistomatoescardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Chemotaxis of monocytes ex vivo

    2 months

  • Antioxidant plasma concentrations

    2 months

Study Arms (2)

tomato ketchup meal

EXPERIMENTAL
Dietary Supplement: tomato ketchup meal

Placebo meal

PLACEBO COMPARATOR
Dietary Supplement: Placebo meal

Interventions

tomato ketchup mealDIETARY_SUPPLEMENT

A single intake of 200 g tomato ketchup together with 200 g white cooked rice.

tomato ketchup meal
Placebo mealDIETARY_SUPPLEMENT

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

Placebo meal

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≤ 30 kg/m2
  • Age \>18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Toxicology, Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 20599665BACKGROUND

  • 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.

    PMID: 21106920BACKGROUND

  • 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.

    PMID: 15719372BACKGROUND

MeSH Terms

Conditions

InflammationChemotaxisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsTaxis ResponseBehavior, AnimalBehaviorOrientation, SpatialSpatial Behavior

Study Officials

  • Aalt Bast, Prof, PhD

    Maastricht University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2011

First Posted

October 31, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

NL(1)