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Vegetable Intake Effect on Heterocyclic Amine Metabolism

Primary Purpose

Colon Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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).
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Cancer focused on measuring HAA, Heterocyclic aromatic amines, apiaceous vegetables, cruciferous vegetables

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Test meal 2 - grilled hamburger with steamed broccoli and Brussels sprouts

Test meal 3 - grilled hamburger with steamed parsnips, fresh parsley, and celery sticks

Test meal 4- grilled hamburger with broccoli, Brussels sprouts, parsnips, parsley and celery sticks

Arm Description

Randomly assigned participants are given grilled hamburger (7 oz) with no vegetables

Randomly assigned participants are given grilled hamburger with steamed broccoli and Brussels sprouts (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)

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).

Outcomes

Primary Outcome Measures

Hydroxylated PhlP profile with cruciferous vegetables
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Hydroxylated PhlP profile with apiaceous vegetables
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
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2021
Last Updated
April 18, 2023
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04882423
Brief Title
Vegetable Intake Effect on Heterocyclic Amine Metabolism
Official Title
Effect of Vegetable Intake on Heterocyclic Amine Metabolism in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
PI left the university
Study Start Date
September 19, 2013 (Actual)
Primary Completion Date
August 31, 2015 (Actual)
Study Completion Date
August 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
HAA, Heterocyclic aromatic amines, apiaceous vegetables, cruciferous vegetables

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test meal 1 - grilled hamburger (7 oz) with no vegetables
Arm Type
Experimental
Arm Description
Randomly assigned participants are given grilled hamburger (7 oz) with no vegetables
Arm Title
Test meal 2 - grilled hamburger with steamed broccoli and Brussels sprouts
Arm Type
Experimental
Arm Description
Randomly assigned participants are given grilled hamburger with steamed broccoli and Brussels sprouts (3g/kg body weight combined)
Arm Title
Test meal 3 - grilled hamburger with steamed parsnips, fresh parsley, and celery sticks
Arm Type
Experimental
Arm Description
Randomly assigned participants are given grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)
Arm Title
Test meal 4- grilled hamburger with broccoli, Brussels sprouts, parsnips, parsley and celery sticks
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
grilled hamburger (7 oz) with no vegetables
Intervention Description
Test meal 1: grilled hamburger (7 oz) with no vegetables
Intervention Type
Other
Intervention Name(s)
grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)
Intervention Description
Test meal 2: grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)
Intervention Type
Other
Intervention Name(s)
grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)
Intervention Description
Test meal 3: grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)
Intervention Type
Other
Intervention Name(s)
grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).
Intervention Description
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).
Primary Outcome Measure Information:
Title
Hydroxylated PhlP profile with cruciferous vegetables
Description
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Time Frame
24 hours
Title
Hydroxylated PhlP profile with apiaceous vegetables
Description
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Time Frame
24 hours
Title
Hydroxylated PhlP profile with both cruciferous and apiaceous vegetables
Description
Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina Trudo, PhD, RD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55108
Country
United States

12. IPD Sharing Statement

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Vegetable Intake Effect on Heterocyclic Amine Metabolism

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