NCT04882423

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. 1.grilled hamburger with no vegetables
  2. 2.grilled hamburger with steamed broccoli and Brussels sprouts
  3. 3.grilled hamburger with steamed parsnips, fresh parsley, and celery sticks
  4. 4.grilled hamburger with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

May 5, 2021

Last Update Submit

April 18, 2023

Conditions

Colon Cancer

Keywords

HAAHeterocyclic aromatic aminesapiaceous vegetablescruciferous vegetables

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

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

EXPERIMENTAL

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

Other: grilled hamburger (7 oz) with no vegetables

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

EXPERIMENTAL

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

EXPERIMENTAL

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

EXPERIMENTAL

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).

Interventions

grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)OTHER

Test meal 2: grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)

Test meal 2 - grilled hamburger with steamed broccoli and Brussels sprouts
grilled hamburger (7 oz) with no vegetablesOTHER

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

Test meal 1 - grilled hamburger (7 oz) with no vegetables
grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)OTHER

Test meal 3: grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)

Test meal 3 - grilled hamburger with steamed parsnips, fresh parsley, and celery sticks
grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).OTHER

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).

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older
  • Healthy
  • Non-smoker

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Sabrina Trudo, PhD, RD

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 12, 2021

Study Start

September 19, 2013

Primary Completion

August 31, 2015

Study Completion

August 31, 2015

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations

US(1)