Vegetable Intake Effect on Heterocyclic Amine Metabolism

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Terminated
CT.gov ID
NCT04882423
Collaborator
(none)
25
1
4
23.4
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: grilled hamburger (7 oz) with no vegetables
  • Other: grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)
  • Other: grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/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).
N/A

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

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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)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)
Primary Purpose:
Prevention
Official Title:
Effect of Vegetable Intake on Heterocyclic Amine Metabolism in Humans
Actual Study Start Date :
Sep 19, 2013
Actual Primary Completion Date :
Aug 31, 2015
Actual Study Completion Date :
Aug 31, 2015

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Hydroxylated PhlP profile with cruciferous vegetables [24 hours]

    Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.

  2. Hydroxylated PhlP profile with apiaceous vegetables [24 hours]

    Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.

  3. Hydroxylated PhlP profile with both cruciferous and apiaceous vegetables [24 hours]

    Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Saint Paul Minnesota United States 55108

Sponsors and Collaborators

  • Masonic Cancer Center, University of Minnesota

Investigators

  • Principal Investigator: Sabrina Trudo, PhD, RD, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT04882423
Other Study ID Numbers:
  • 2013NTLS067
First Posted:
May 12, 2021
Last Update Posted:
May 12, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Masonic Cancer Center, University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2021