Sugar-Sweetened Beverage (SSB) and Racial Disparities of Right Vs Left Colon Epigenetic Aging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Change from baseline sugar-sweetened beverages
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Baseline Study:
- •Inclusion Criteria:
- •Patients scheduled for a colonoscopy (large polyp removal)
- •Patients 18+
排除标准
- •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).
结局指标
主要结局
Change from baseline sugar-sweetened beverages
时间窗: Baseline, 9-weeks, 6-months, 18 months
Measured using the Beverage Questionnaire 15 (BEVQ-15), measured in oz
次要结局
- Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 6 months.(Baseline, 6 months)
- Degree of physiological aging, assessed by DNA methylation, of right vs. left colorectal tissue biopsies at Baseline and 18 months.(Baseline, 18 months)
- Change from baseline dietary quality as measured by the components of the Healthy Eating Index (HEI)(Baseline, 9-weeks, 6-months, 18 months)
研究者
Li Li
Principal Investigator
University of Virginia