Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01344330

Enrollment

108

Registered

2011-04-29

Start date

2012-01-31

Completion date

2017-12-31

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Colon cancer, Prevention, Cruciferous vegetables, Histone status

Brief summary

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Cruciferous vegetable intake correlated with SFN and I3C urinary metabolites	At colonoscopy (day 1)

Secondary

Measure	Time frame
Cruciferous vegetable intake and p21 expression (qRT-PCR, ChIP in PBMCs)	at colonoscopy
Cruciferous vegetable intake correlated with acetylated histone expression (PBMCs, colon tissue),	at colonoscopy
Cruciferous vegetable intake correlated with HDAC activity (in PBMCs)	at colonoscopy

Countries

United States

Outcome results