Vegetable Intake Effect on Heterocyclic Amine Metabolism

April 18, 2023 updated by: Masonic Cancer Center, University of Minnesota

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:

  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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55108
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test meal 1 - grilled hamburger (7 oz) with no vegetables
Randomly assigned participants are given grilled hamburger (7 oz) with no vegetables
Other: grilled hamburger (7 oz) with no vegetables
Test meal 1: grilled hamburger (7 oz) with no vegetables
Experimental: Test meal 2 - grilled hamburger with steamed broccoli and Brussels sprouts
Randomly assigned participants are given grilled hamburger with steamed broccoli and Brussels sprouts (3g/kg body weight combined)
Other: 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)
Experimental: Test meal 3 - grilled hamburger with steamed parsnips, fresh parsley, and celery sticks
Randomly assigned participants are given grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)
Other: 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)
Experimental: Test meal 4- grilled hamburger with broccoli, Brussels sprouts, parsnips, parsley and celery sticks
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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
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.
24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2013

Primary Completion (Actual)

August 31, 2015

Study Completion (Actual)

August 31, 2015

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 8, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013NTLS067

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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