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Vegetable Intake Effect on Heterocyclic Amine Metabolism

Effect of Vegetable Intake on Heterocyclic Amine Metabolism in Humans

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04882423
Enrollment
25
Registered
2021-05-12
Start date
2013-09-19
Completion date
2015-08-31
Last updated
2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

HAA, Heterocyclic aromatic amines, apiaceous vegetables, cruciferous vegetables

Brief 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. 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: 1. grilled hamburger with no vegetables 2. grilled hamburger with steamed broccoli and Brussels sprouts 3. grilled hamburger with steamed parsnips, fresh parsley, and celery sticks 4. 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.

Interventions

OTHERgrilled hamburger (7 oz) with no vegetables

Test meal 1: grilled hamburger (7 oz) with no vegetables

OTHERgrilled 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)

OTHERgrilled 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)

OTHERgrilled 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).

Sponsors

Masonic Cancer Center, University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention 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)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years old or older * Healthy * Non-smoker

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Hydroxylated PhlP profile with cruciferous vegetables24 hoursQuantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Hydroxylated PhlP profile with apiaceous vegetables24 hoursQuantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Hydroxylated PhlP profile with both cruciferous and apiaceous vegetables24 hoursQuantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026