NCT03955510Active, not recruiting
Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to study the impact of Western lifestyle, including moderate alcohol consumption and delayed eating patterns on studying individuals' susceptibility to colorectal cancer. This study aims to increase our ability to identify individuals at risk for colorectal cancer in the future. Each subject will experience four conditions (each for one week in duration with a week +/- 2 days wash-out in between): (1) "right-time eating" / no alcohol, (2) "right-time eating" / with alcohol, (3) "delayed-eating" / no alcohol, (4) "delayed-eating" / with alcohol. The order of experiments will be randomized \[concealed randomization\]. All subjects will undergo unprepped sigmoidoscopy after each week of intervention. In Aim 2, all subjects will have an option to undergo a 24h circadian assessment in the Biological Rhythms Research Lab after each week of intervention. The Investigator will assess (i) central circadian rhythms by collecting hourly salivary samples for melatonin assays and (ii) peripheral rhythm in the intestinal tract by buccal swabs once every 2h (12 time points) as well as by rectal sampling twice (every 12 hr). For Aim 3, sigmoidoscopy without sedation will be used to obtain colonic samples as the safe method compared to colonoscopy, which has some small but finite risks associated with the procedure (e.g, bleeding or perforation) as well as sedation.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 8 Apr 2019
- Start date
- 31 Jul 2016
- Primary completion date
- 31 May 2023
- Lead sponsor
- Rush University Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT03955510
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 31 Jul 2016 to the primary completion date, 31 May 2023
- 1 site in 1 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.
Prior treatment
- Presence of comorbidities that might affect the circadian system
- Chronic renal failure
- Cirrhosis
- Advanced neurological conditions (e.g., Parkinson's, MS, epilepsy)
- Psychological disorders (e.g., PTSD, major depression)
- Sleep apnea
- Restless Leg Syndrome
- Inpatient Status
- Advanced cardiac failure
- Night shift workers with active shift work in the past month
- Planned shift work that will occur during the study
- Crossed more than two time zones in the previous week
- Conditions that alter the microbiota (infection or recent history of antibiotic use within three months, or use of pro/prebiotics within one month prior to recruitment)
- Regular use of medications that can potentially affect melatonin profiles (e.g., Melatonin, Metoclopramide, Psychotropic medications, Hypnotics during the four weeks prior to the study)
Other illness
- Alcohol use disorder/Alcohol Abuse
- A known genetic predisposition to colorectal cancer (FAP, Lynch syndrome)
- A history of colorectal cancer or inflammatory bowel diseases
- Conditions that alter or necessitate a particular eating pattern (e.g., uncontrolled diabetes, eating disorders)
- Any active cancer
Other
- Asian ethnicity (Due to common polymorphisms of enzymes involved in alcohol metabolism)
- Does not drink alcohol
- Inability to sign an informed consent
Who the study is looking for
- Adults (greater than 21 years old)
- Have had advanced tubular adenoma within the last year
Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.