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Active Not Recruiting
NCT03955510
Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis
Conditions: Colorectal Cancer
Sex: All
Ages: 21 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Rush University Medical Center
Location: Rush University Medical Center Chicago Illinois
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Adults (greater than 21 years old)
2. Have had advanced tubular adenoma within the last year
Exclusion Criteria:
1. Asian ethnicity (Due to common polymorphisms of enzymes involved in alcohol metabolism)
2. Does not drink alcohol
3. Alcohol use disorder/Alcohol Abuse
4. A known genetic predisposition to colorectal cancer (FAP, Lynch syndrome)
5. A history of colorectal cancer or inflammatory bowel diseases
6. Presence of comorbidities that might affect the circadian system
1. Chronic renal failure
2. Cirrhosis
3. Advanced neurological conditions (e.g., Parkinson's, MS, epilepsy)
4. Psychological disorders (e.g., PTSD, major depression)
5. Sleep apnea
6. Restless Leg Syndrome
7. Inpatient Status
8. Advanced cardiac failure
9. Night shift workers with active shift work in the past month
10. Planned shift work that will occur during the study
11. Crossed more than two time zones in the previous week
7. Conditions that alter or necessitate a particular eating pattern (e.g., uncontrolled diabetes, eating disorders)
8. 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)
9. 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)
10. Any active cancer
11. Inability to sign an informed consent
Source: ClinicalTrials.gov (NCT03955510). StuddyBuddy aggregates publicly available trial information.