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OpenTrials
Completed

NCT Number: NCT01344330

Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

This research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of cruciferous vegetable intake.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • scheduled for screening colonoscopy
  • off NSAID or aspirin therapy in accordance with OHSU endoscopy clinic guidelines
  • INR 0.90-1.20
  • hemoglobin ≥ 13.5 (men) or 12.0 (women)
  • platelets ≥100,000/μL
  • Chem screen results within normal limits
  • negative (serum or urine) pregnancy test done ≤7 days prior to colonoscopy for women of childbearing potential only
  • ASA performance status <2

Exclusion criteria

  • history of colon cancer or adenomatous polyps
  • current smoker
  • medical history of chronic obstructive pulmonary disease
  • current oral steroid therapy
  • current therapy with valproate or other pharmacological drugs associated with HDAC inhibition
  • use of oral antibiotics within 3 months prior to entry into study
  • significant active medical illness which in the opinion of the investigator would preclude collection/interpretation of colon tissue
  • diagnosis of hemophilia, van Willebrand's disease or other bleeding disorder
  • use of warfarin or other blood thinning agents
  • inflammatory bowel disease.

Treatment and study plan

Primary outcomes

  1. Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites

    Time frame: At colonoscopy (day 1)

Secondary outcomes

  1. Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs)

    Time frame: at colonoscopy

  2. Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue),

    Time frame: at colonoscopy

  3. Cruciferous vegetable intake correlated with HDAC activity (in PBMCs)

    Time frame: at colonoscopy

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • National Cancer Institute (NCI)
  • Oregon Health and Science University

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2011
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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