NCT06669923Not yet recruiting
Understanding Sugar-Sweetened Beverages (SSB) and Colorectal Cancer (CRC)
Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging
Source: ClinicalTrials.gov · Last updated 1 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 29 Jan 2024
- Start date
- 15 Nov 2024
- Primary completion date
- 15 Nov 2029
- Lead sponsor
- University of Virginia
- Diseases
- Colorectal cancer
- NCT number
- NCT06669923
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 15 Nov 2024 to the primary completion date, 15 Nov 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects diagnosed with inflammatory bowel disorder
- Subjects diagnosed with cancer (except non-melanoma skin cancer)
Other
- Subjects who do not speak English
- 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:
Who the study is looking for
- Patients scheduled for a colonoscopy (large polyp removal)
- Patients 18+
- 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).
Criteria the registry did not label
- Baseline Study:
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.