Clinical Trials Directory

Trials / Terminated

TerminatedNCT04882423

Vegetable Intake Effect on Heterocyclic Amine Metabolism

Effect of Vegetable Intake on Heterocyclic Amine Metabolism in Humans

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Masonic Cancer Center, University of Minnesota · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERgrilled hamburger (7 oz) with no vegetablesTest 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).

Timeline

Start date
2013-09-19
Primary completion
2015-08-31
Completion
2015-08-31
First posted
2021-05-12
Last updated
2023-04-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04882423. Inclusion in this directory is not an endorsement.