InflammationTOMNCT00966550
A Study of Tomato Products and Disease Risk
A study testing Tomato and Non-tomato in people with Inflammation, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The purpose of this research study is to test whether certain compounds in tomatoes will help reduce factors in the subject's blood associated with disease risk. The investigators want to know if the tomato-associated compounds will lower or improve the status of these factors, like cholesterol and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Tomato and Non-tomato
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female
- Between ages of 18-65
- BMI between 19 and 24 and hsCRP < 1mg/L
- BMI between 25 and 35 and hsCRP > 2.5mg/L
- No clinical evidence of cardiovascular, respiratory, renal, GI or hepatic disease
Who cannot join
- Pregnant and/or lactating
- allergies or intolerances to foods consumed in the study
- fasting blood glucose > 110mg/dL
- taking OTC antioxidant supplements, prescription meds that may interfere with study endpoints
- unusual dietary habits
- actively trying to lose or gain weight
Show all 9Show fewer
- addicted to drugs or alcohol
- medically documented psychiatric or neurological disturbances
- smoker (past smoker allowed if cessation > 2 years)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Tomato Products and Postprandial Oxidation and Inflammation: a Clinical Trial in Healthy Weight Men and Women
The purpose of this research study is to test whether certain compounds in tomatoes will help reduce factors in the subject's blood associated with disease risk. The investigators want to know if the tomato-associated compounds will lower or improve the status of these factors, like cholesterol and inflammation. In this research study, the subject will be asked to consume high fat test meals on two separate occasions. The investigators want to see how the subject's body responds to a standard high fat meal, one meal with tomato products and one meal without tomato products. The investigators will measure the subject's blood throughout the study period to determine if consumption of tomato products reduces factors in their blood associated with disease risk.
Read the detailed description
This study will take three weeks at most, and require one initial screening visit lasting approximately 45 minutes and two study visits each lasting approximately 6 - 8 hours. The investigators are looking for healthy, non-smoking male and female volunteers between the ages of 18 - 65, with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.
The initial screening visit will determine subject' eligibility through height, weight and waist circumference measurements, blood glucose (finger prick) test and a fasting screening blood draw. There will be no compensation for the screening visit, other than transportation costs.
If subject qualify, subject will continue to the two study visits. Each visit will require subject to have blood drawn several times during subject' study visit (total amount of blood equal to approximately 1 ½ tablespoons). To make this process more tolerable, a registered nurse will place a catheter (similar to what happens when you give blood) into subject's vein for ease in drawing blood. After the catheter placement and the first blood draw, subject will be asked to eat the test meal (tomato or non-tomato meal) and then subject will continue to have blood taken at specific time points for the next 6 hours. The investigators will also do an ultrasound on subject's arm to measure blood flow both before eating and midway through the 6 - hour study visit. The investigators will ask that subject not consume tomatoes or tomato products during the course of the study and record all food and beverages consumed on certain days.
- Conditions
- Inflammation
- Being tested
- Tomato, Non-tomato
- Keywords
- Tomato, Nutrition
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TomatoOther
Also called Active Comparator
Tomato with high carb/fat meal
Non-tomatoOther
Also called Placebo Comparator
Non-tomato with high carb/fat meal
| Study group | Role | What they receive |
|---|---|---|
| Tomato | Active comparator | Tomato with high carb/fat meal Receives: Other: Tomato |
| Non-Tomato | Placebo comparator | Non-tomato with high carb/fat meal Receives: Other: Non-tomato |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 Concentrations
Measured: 6 hour postprandial study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tomato Products Wellness Council
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, MS, PhD, Principal investigator, Clinical Nutrition Research Center, Illinois Institute of TechnologyIndika Edirisinghe, PhD, Principal investigator, Clinical Nutrition Research Center, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966550
- Sponsor's protocol ID
- TOM 2009-071
- Acronym
- TOM
- Status last verified
- Feb 2017
- First submitted
- 26 Aug 2009
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Burton-Freeman B, Talbot J, Park E, Krishnankutty S, Edirisinghe I. Protective activity of processed tomato products on postprandial oxidation and inflammation: a clinical trial in healthy weight men and women. Mol Nutr Food Res. 2012 Apr;56(4):622-31. doi: 10.1002/mnfr.201100649. Epub 2012 Feb 14.
PubMed 22331646
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomato Products and Postprandial Oxidation and Inflammation: a Clinical Trial in Healthy Weight Men and Women
- ClinicalTrials.gov ID
- NCT00966550
- Acronym / sponsor ID
- TOM / TOM 2009-071
- Conditions
- Inflammation
- Keywords
- Tomato, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Tomato Products Wellness Council
- Study start
- Aug 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 16 Oct 2014
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 research study is to test whether certain compounds in tomatoes will help reduce factors in the subject's blood associated with disease risk. The investigators want to know if the tomato-associated compounds will lower or improve the status of these factors, like cholesterol and inflammation. In this research study, the subject will be asked to consume high fat test meals on two separate occasions. The investigators want to see how the subject's body responds to a standard high fat meal, one meal with tomato products and one meal without tomato products. The investigators will measure the subject's blood throughout the study period to determine if consumption of tomato products reduces factors in their blood associated with disease risk.
Detailed description
This study will take three weeks at most, and require one initial screening visit lasting approximately 45 minutes and two study visits each lasting approximately 6 - 8 hours. The investigators are looking for healthy, non-smoking male and female volunteers between the ages of 18 - 65, with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.
The initial screening visit will determine subject' eligibility through height, weight and waist circumference measurements, blood glucose (finger prick) test and a fasting screening blood draw. There will be no compensation for the screening visit, other than transportation costs.
If subject qualify, subject will continue to the two study visits. Each visit will require subject to have blood drawn several times during subject' study visit (total amount of blood equal to approximately 1 ½ tablespoons). To make this process more tolerable, a registered nurse will place a catheter (similar to what happens when you give blood) into subject's vein for ease in drawing blood. After the catheter placement and the first blood draw, subject will be asked to eat the test meal (tomato or non-tomato meal) and then subject will continue to have blood taken at specific time points for the next 6 hours. The investigators will also do an ultrasound on subject's arm to measure blood flow both before eating and midway through the 6 - hour study visit. The investigators will ask that subject not consume tomatoes or tomato products during the course of the study and record all food and beverages consumed on certain days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tomato | Active comparator | Other: TomatoTomato with high carb/fat meal |
| Non-Tomato | Placebo comparator | Other: Non-tomatoNon-tomato with high carb/fat meal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female
- Between ages of 18-65
- BMI between 19 and 24 and hsCRP < 1mg/L
- BMI between 25 and 35 and hsCRP > 2.5mg/L
- No clinical evidence of cardiovascular, respiratory, renal, GI or hepatic disease
Key exclusion criteria (9 listed)
- Pregnant and/or lactating
- allergies or intolerances to foods consumed in the study
- fasting blood glucose > 110mg/dL
- taking OTC antioxidant supplements, prescription meds that may interfere with study endpoints
- unusual dietary habits
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 |
|---|---|---|
| TomatoAlso: Active ComparatorTomato with high carb/fat meal | Other | Tomato |
| Non-tomatoAlso: Placebo ComparatorNon-tomato with high carb/fat meal | Other | Non-Tomato |
Primary outcome
IL-6 Concentrations
Time frame: 6 hour postprandial study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22331646Burton-Freeman B, Talbot J, Park E, Krishnankutty S, Edirisinghe I. Protective activity of processed tomato products on postprandial oxidation and inflammation: a clinical trial in healthy weight men and women. Mol Nutr Food Res. 2012 Apr;56(4):622-31. doi: 10.1002/mnfr.201100649. Epub 2012 Feb 14.
- Individual participant dataSharing planned: Undecided
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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.
Britt Burton-Freeman, MS, PhD principal investigator
Clinical Nutrition Research Center, Illinois Institute of Technology
Indika Edirisinghe, PhD principal investigator
Clinical Nutrition Research Center, Illinois Institute of Technology
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 and Non-tomato in people with Inflammation, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
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 5 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 14 Mar 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
IL-6 Concentrations (time frame: 6 hour postprandial study). 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 NCT00966550, which also lists 1 linked publication.
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 14 Mar 2017.