Vegetable Intake Effect on Heterocyclic Amine Metabolism

Colon Cancer Clinical Trial

Official title:

Effect of Vegetable Intake on Heterocyclic Amine Metabolism in Humans

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04882423
• Other study ID #: 2013NTLS067
• Status: Terminated
• Phase: N/A
• Start date: September 19, 2013
• Est. completion date: August 31, 2015

Study information

• Verified date: April 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: August 31, 2015
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydroxylated PhlP profile with cruciferous vegetables	Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.	24 hours
Primary	Hydroxylated PhlP profile with apiaceous vegetables	Quantify Hydroxylated PhlP in ng per ml of urine will be measured using LC-MS metabolomics approach.	24 hours
Primary	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.	24 hours