InflammationNCT01462825
The Effect of Tomato Ketchup on Inflammation
A study testing tomato ketchup meal in people with Inflammation, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- tomato ketchup meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≤ 30 kg/m2
- Age >18 years
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept. of Toxicology, Maastricht University Medical Centre
Maastricht
About this study
Official title: The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood
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.
Read the 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.
- Conditions
- Inflammation
- Being tested
- tomato ketchup meal, Placebo meal
- Keywords
- Inflammation, cytokines, chemotaxis, tomatoes, cardiovascular disease
- Medical subject headings
- Inflammation, Chemotaxis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tomato ketchup mealDietary supplement
A single intake of 200 g tomato ketchup together with 200 g white cooked rice.
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
| Study group | Role | What they receive |
|---|---|---|
| tomato ketchup meal | Experimental | Not described Receives: Dietary Supplement: tomato ketchup meal |
| Placebo meal | Placebo comparator | Not described Receives: Dietary Supplement: Placebo meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months
Secondary outcomes (2)
Chemotaxis of monocytes ex vivo
Measured: 2 months
Antioxidant plasma concentrations
Quantification of lycopene, its stereoisomers, alpha-tocopherol, ascorbic acid in plasma
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antje Weseler, Maastricht University Medical Center
- Investigators
- Aalt Bast, Prof, PhD, Study director, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462825
- Sponsor's protocol ID
- METC11-3-049
- Status last verified
- Dec 2012
- First submitted
- 6 Sep 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20599665Mateo 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.
PubMed 21106920Swennen 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.
PubMed 15719372
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Tomato Ketchup Consumption on Inflammation Induced Ex-vivo in Human Blood
- ClinicalTrials.gov ID
- NCT01462825
- Acronym / sponsor ID
- METC11-3-049
- Conditions
- Inflammation
- Keywords
- Inflammation, cytokines, chemotaxis, tomatoes, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tomato ketchup meal | Experimental | Dietary Supplement: tomato ketchup meal |
| Placebo meal | Placebo comparator | Dietary Supplement: Placebo meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≤ 30 kg/m2
- Age >18 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tomato ketchup mealA single intake of 200 g tomato ketchup together with 200 g white cooked rice. | Dietary supplement | tomato ketchup meal |
| Placebo mealSelf-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 | Dietary supplement | Placebo meal |
Primary outcome
Release of pro-and anti-inflammatory cytokines ex vivo
Time frame: 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)
2 secondary outcomes
Chemotaxis of monocytes ex vivo
Time frame: 2 months
Antioxidant plasma concentrations
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- Background: PubMed 20599665Palozza 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.
- Background: PubMed 21106920Mateo 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.
- Background: PubMed 15719372Swennen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aalt Bast, Prof, PhD study director
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tomato ketchup meal in people with Inflammation, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Release of pro-and anti-inflammatory cytokines ex vivo (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01462825, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.