Clinical trial NCT06669923: Understanding Sugar-Sweetened Beverages (SSB) and Colorectal Cancer (CRC)
Official title: Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will recruit and consent approximately 120 subjects in the baseline study until the follow-up study recruitment goals of 20 subjects is met. This pilot proposal to: Aim 1) assess the feasibility of conducting a randomized controlled trial of iSIPsmarter among high-risk patients with newly detected large colorectal adenoma to reduce Sugar-Sweetened Beverages (SSB) consumption, and Aim 2) examine the investigators' central hypothesis that SSBs contribute to racial disparities in the development of side-specific colon neoplasia via differentially impacting epigenetic aging and methylation of right vs. left normal colon tissues of African-Americans (AA) vs European-Americans (EA). In order to do so, the investigators will first conduct a study to collect baseline information from eligible and interested participants. Behavioral, lifestyle, and genetic information will be collected from participants undergoing a colonoscopy with large polypectomy removal to set up a biobank. The participants enrolled in this study will then be screened for their interest and eligibility in participating in the follow-up study, a randomized iSIPsmarter intervention trial. The investigators will enroll 20 patients in the follow-up study (1:1 ratio intervention vs. control; equal number of AAs and EAs) with newly detected/resected large colorectal adenomas to collect normal colon tissue biopsies pre- and post-iSIPsmarter intervention and test the investigators' hypotheses.


Eligibility criteria: Baseline Study:

Inclusion Criteria:

* Patients scheduled for a colonoscopy (large polyp removal)
* Patients 18+

Exclusion Criteria:

* Subjects who do not speak English
* Subjects diagnosed with inflammatory bowel disorder
* Subjects diagnosed with cancer (except non-melanoma skin cancer)
* Subjects taking blood thinners at time of colonoscopy (except 325 mg daily aspirin)

Follow-up Study:

In order to be eligible to participate in the f/up study, an individual must meet all of the criteria for the Baseline study AND:

Inclusion Criteria:

* Regular access (\<1/week) to the internet.
* Drink more than recommended amount of sugar-sweetened beverages per day (assessed from participant's responses to the Beverage Questionnaire section (BEVQ-15) of the Computer Administered Phone Interview (CAPI), from the Baseline study).

Primary outcomes:
measure: Change from baseline sugar-sweetened beverages
timeFrame: Baseline, 9-weeks, 6-months, 18 months
Secondary outcomes:
measure: Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 6 months.
timeFrame: Baseline, 6 months
measure: Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 18 months.
timeFrame: Baseline, 18 months
measure: Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI)
timeFrame: Baseline, 9-weeks, 6-months, 18 months
Other outcomes:
Locations:
Study officials:
affiliation: UVA, Dept of Family Medicine
name: Li Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UVA, Dept of Public Health Sciences
name: Jamie Zoellner, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: