Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iSIPsmarter Program | Behavioral | — | UNRESOLVED |
| Patient Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Baseline
- description
- Baseline study collects baseline data and screens for potential participants for the follow-up study.
- type
- SHAM_COMPARATOR
- label
- Follow Up - Patient Education Group
- interventionNames
- Behavioral: Patient Education
- type
- EXPERIMENTAL
- label
- Follow Up - iSIPsmarter Program Group
- interventionNames
- Behavioral: iSIPsmarter Program
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available