Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06669923

Understanding Sugar-Sweetened Beverages (SSB) and Colorectal Cancer (CRC)

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

iSIPsmarter Program

Behavioral

web-based behavioral intervention to reduce sugary drink intake

Other names: Sugary Drink Program

Patient education

Behavioral

website with information about cancer screening and prevention (e.g. screening tests for seven types of cancer)

Other names: Cancer Prevention Program

Primary outcomes

  1. Change from baseline sugar-sweetened beverages

    Time frame: Baseline, 9-weeks, 6-months, 18 months

    Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz

Secondary outcomes

  1. Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 6 months.

    Time frame: Baseline, 6 months

    Measured by comparing baseline physiological aging of right vs. left colon tissue biopsies with biopsies collected 6 months post-intervention.

  2. Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 18 months.

    Time frame: Baseline, 18 months

    Measured by comparing baseline physiological aging of right vs. left colon tissue biopsies with biopsies collected 18 months post-intervention.

  3. Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI)

    Time frame: Baseline, 9-weeks, 6-months, 18 months

    2 unannounced recalls (one weekend and one weekday) using state-of-the-art Nutrition Data System for Research (NDSR) software and multiple pass methods. HEI indicators will be extracted from the NDSR system and examined for changes in the total HEI score, on a 100-point continuous scale (higher scores reflective higher diet quality)

Study contacts

Contact information is provided by the study sponsor or research team.

Donna-Jean Brock, MA

CONTACT

[email protected]

434-962-5870

Samyukta Venkatesh, BA

CONTACT

[email protected]

4342434983

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging

Acronym: SSB and CRC

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

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.

Published trials that share one or more normalized conditions with this study.