Colon CancerNCT04882423
Vegetable Intake Effect on Heterocyclic Amine Metabolism
A study testing grilled hamburger (7 oz) with no vegetables, grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined) and grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined) in people with Colon Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a randomized trial with crossover design, where each participant will undergo four study phases with a different test meal at the end of each phase. Every phase will consist of subjects consuming for six days their normal diet excluding cruciferous and apiaceous vegetables, alcohol, and caffeine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- grilled hamburger (7 oz) with no vegetables, grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined) and grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2013to 31 Aug 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Healthy
- Non-smoker
Who cannot join
- No history of gastrointestinal, hepatic, or renal disorders
- Not currently taking any prescription or over-the-counter medications
- Not currently taking any herbal/vitamins supplements
- Not pregnant or lactating
- No allergies or intolerances to the foods that will be used in the study (parsnips, parsley, celery, broccoli, Brussels sprouts, and hamburger)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: Effect of Vegetable Intake on Heterocyclic Amine Metabolism in Humans
This is a randomized trial with crossover design, where each participant will undergo four study phases with a different test meal at the end of each phase. Every phase will consist of subjects consuming for six days their normal diet excluding cruciferous and apiaceous vegetables, alcohol, and caffeine. The participants will refrain from meat products for 24 hours prior to the test meal. On day seven of each phase and after an overnight fast, subjects will be randomly assigned to eat one of four meals:
- grilled hamburger with no vegetables
- grilled hamburger with steamed broccoli and Brussels sprouts
- grilled hamburger with steamed parsnips, fresh parsley, and celery sticks
- grilled hamburger with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks.
Read the detailed description
Colon cancer is the third most common cancer in the U.S. Convincing evidence suggests that high intake of red meat increases colon cancer risk, according to the 2007 AICR/WCRF Second Expert Report. The likely responsible mutagens are heterocyclic aromatic amines (HAA), which form naturally during the cooking of meat, poultry, and fish at high temperatures. Bioactivation of HAA to carcinogenic metabolites is primarily mediated by phase I biotransformation enzymes. Evidence suggests that the activity of many of these enzymes can be modulated by constituents in apiaceous vegetables (parsnips, celery, etc.) and cruciferous vegetables (broccoli, cabbage, etc.)
In this trial researchers are comparing the effects of eating cruciferous vegetables, apiaceous vegetables, or both groups combined on HAA metabolism after eating grilled hamburger together in a single meal. They aim to define optimal dietary patterns and food combinations that maximize the safe excretion of dietary carcinogens through this trial. This contribution is significant because the knowledge gained will be applicable to the prevention of colon cancer as well as additional cancers.
- Conditions
- Colon Cancer
- Being tested
- grilled hamburger (7 oz) with no vegetables, grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined), grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined), grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).
- Keywords
- HAA, Heterocyclic aromatic amines, apiaceous vegetables, cruciferous vegetables
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grilled hamburger (7 oz) with no vegetablesOther
Test meal 1: grilled hamburger (7 oz) with no vegetables
grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)Other
Test meal 2: grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)
grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)Other
Test meal 3: grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)
grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).Other
Test meal 4: grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).
| Study group | Role | What they receive |
|---|---|---|
| Test meal 1 - grilled hamburger (7 oz) with no vegetables | Experimental | Randomly assigned participants are given grilled hamburger (7 oz) with no vegetables Receives: Other: grilled hamburger (7 oz) with no vegetables |
| Test meal 2 - grilled hamburger with steamed broccoli and Brussels sprouts | Experimental | Randomly assigned participants are given grilled hamburger with steamed broccoli and Brussels sprouts (3g/kg body weight combined) Receives: Other: grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined) |
| Test meal 3 - grilled hamburger with steamed parsnips, fresh parsley, and celery sticks | Experimental | Randomly assigned participants are given grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined) Receives: Other: grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined) |
| Test meal 4- grilled hamburger with broccoli, Brussels sprouts, parsnips, parsley and celery sticks | Experimental | Randomly assigned participants are given grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined). Receives: Other: grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydroxylated PhlP profile with cruciferous vegetables
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Measured: 24 hours
Hydroxylated PhlP profile with apiaceous vegetables
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Measured: 24 hours
Hydroxylated PhlP profile with both cruciferous and apiaceous vegetables
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start19 Sep 2013
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
Why it stopped: PI left the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a randomized crossover design, each participant will undergo four study phases with a different test meal at the end of each phase. Every phase will consist of subjects consuming for six days their normal diet excluding cruciferous and apiaceous vegetables, alcohol, and caffeine. Furthermore, participants will refrain from meat products for 24 hours prior to the test meal, given that HAA are generally excreted in the urine by 12 hours post ingestion (18, 80). Compliance will be assessed with a questionnaire and the analysis of baseline levels of phytochemicals in spot urine samples that are to be collected prior to the test meal. On day seven of each phase and after an overnight fast, subjects will be randomly assigned to eat (in a private room near Dr. Truda's lab) one of four meals (prepared in a food grade lab also near Dr. Truda's lab)
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina Trudo, PhD, RD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882423
- Sponsor's protocol ID
- 2013NTLS067
- Status last verified
- Apr 2023
- First submitted
- 5 May 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vegetable Intake on Heterocyclic Amine Metabolism in Humans
- ClinicalTrials.gov ID
- NCT04882423
- Acronym / sponsor ID
- 2013NTLS067
- Conditions
- Colon Cancer
- Keywords
- HAA, Heterocyclic aromatic amines, apiaceous vegetables, cruciferous vegetables
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the university
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 19 Sep 2013 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 12 May 2021 (actual)
- 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.
This is a randomized trial with crossover design, where each participant will undergo four study phases with a different test meal at the end of each phase. Every phase will consist of subjects consuming for six days their normal diet excluding cruciferous and apiaceous vegetables, alcohol, and caffeine. The participants will refrain from meat products for 24 hours prior to the test meal. On day seven of each phase and after an overnight fast, subjects will be randomly assigned to eat one of four meals:
- grilled hamburger with no vegetables
- grilled hamburger with steamed broccoli and Brussels sprouts
- grilled hamburger with steamed parsnips, fresh parsley, and celery sticks
- grilled hamburger with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks.
Detailed description
Colon cancer is the third most common cancer in the U.S. Convincing evidence suggests that high intake of red meat increases colon cancer risk, according to the 2007 AICR/WCRF Second Expert Report. The likely responsible mutagens are heterocyclic aromatic amines (HAA), which form naturally during the cooking of meat, poultry, and fish at high temperatures. Bioactivation of HAA to carcinogenic metabolites is primarily mediated by phase I biotransformation enzymes. Evidence suggests that the activity of many of these enzymes can be modulated by constituents in apiaceous vegetables (parsnips, celery, etc.) and cruciferous vegetables (broccoli, cabbage, etc.)
In this trial researchers are comparing the effects of eating cruciferous vegetables, apiaceous vegetables, or both groups combined on HAA metabolism after eating grilled hamburger together in a single meal. They aim to define optimal dietary patterns and food combinations that maximize the safe excretion of dietary carcinogens through this trial. This contribution is significant because the knowledge gained will be applicable to the prevention of colon cancer as well as additional cancers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In a randomized crossover design, each participant will undergo four study phases with a different test meal at the end of each phase. Every phase will consist of subjects consuming for six days their normal diet excluding cruciferous and apiaceous vegetables, alcohol, and caffeine. Furthermore, participants will refrain from meat products for 24 hours prior to the test meal, given that HAA are generally excreted in the urine by 12 hours post ingestion (18, 80). Compliance will be assessed with a questionnaire and the analysis of baseline levels of phytochemicals in spot urine samples that are to be collected prior to the test meal. On day seven of each phase and after an overnight fast, subjects will be randomly assigned to eat (in a private room near Dr. Truda's lab) one of four meals (prepared in a food grade lab also near Dr. Truda's lab)
| Arm | Type | Receives |
|---|---|---|
| Test meal 1 - grilled hamburger (7 oz) with no vegetables | Experimental | Other: grilled hamburger (7 oz) with no vegetablesRandomly assigned participants are given grilled hamburger (7 oz) with no vegetables |
| Test meal 2 - grilled hamburger with steamed broccoli and Brussels sprouts | Experimental | Other: grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)Randomly assigned participants are given grilled hamburger with steamed broccoli and Brussels sprouts (3g/kg body weight combined) |
| Test meal 3 - grilled hamburger with steamed parsnips, fresh parsley, and celery sticks | Experimental | Other: grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)Randomly assigned participants are given grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined) |
| Test meal 4- grilled hamburger with broccoli, Brussels sprouts, parsnips, parsley and celery sticks | Experimental | Other: grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).Randomly assigned participants are given grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older
- Healthy
- Non-smoker
Key exclusion criteria (5 listed)
- No history of gastrointestinal, hepatic, or renal disorders
- Not currently taking any prescription or over-the-counter medications
- Not currently taking any herbal/vitamins supplements
- Not pregnant or lactating
- No allergies or intolerances to the foods that will be used in the study (parsnips, parsley, celery, broccoli, Brussels sprouts, and hamburger)
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 |
|---|---|---|
| grilled hamburger (7 oz) with no vegetablesTest meal 1: grilled hamburger (7 oz) with no vegetables | Other | Test meal 1 - grilled hamburger (7 oz) with no vegetables |
| grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)Test meal 2: grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined) | Other | Test meal 2 - grilled hamburger with steamed broccoli and Brussels sprouts |
| grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)Test meal 3: grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined) | Other | Test meal 3 - grilled hamburger with steamed parsnips, fresh parsley, and celery sticks |
| grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).Test meal 4: grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined). | Other | Test meal 4- grilled hamburger with broccoli, Brussels sprouts, parsnips, parsley and celery sticks |
Primary outcome
Hydroxylated PhlP profile with cruciferous vegetables
Time frame: 24 hours
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Hydroxylated PhlP profile with apiaceous vegetables
Time frame: 24 hours
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Hydroxylated PhlP profile with both cruciferous and apiaceous vegetables
Time frame: 24 hours
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Results and safety
The study was stopped early (reason given: PI left the university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
Related trials for Colon Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
Recruiting
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Colorectal Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Colorectal Cancer (CRC) Screening
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.
Sabrina Trudo, PhD, RD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing grilled hamburger (7 oz) with no vegetables, grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined) and grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined) in people with Colon Cancer, run by Masonic Cancer Center, University of Minnesota 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Apr 2023. 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. 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 was stopped early (reason given: PI left the university). Results are not available in the source record.
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?
Hydroxylated PhlP profile with cruciferous vegetables (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023.