Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis (AFT)

  • STATUS
    Recruiting
  • End date
    Nov 13, 2023
  • participants needed
    44
  • sponsor
    Rush University Medical Center
Updated on 13 July 2022
adenoma

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.

Description

Colorectal cancer (CRC) is the second leading cause of cancer mortality in the US. CRC's risk is closely linked to the modern lifestyle. Alcohol is commonly used in our society and is an established risk factor for both pre-cancerous (polyp) and cancerous lesions of the colon. However this knowledge has not been translated to our current risk stratifications for CRC as the process of alcohol-induced carcinogenesis is not predictable. Mucosal inflammation is a well-established mechanism that mediates the effect of alcohol induced tissue injury in the intestine. Inflammation also plays a crucial role in pathogenesis of CRC. Factors that promote a pro-tumorigenic inflammatory state in the setting of alcohol are unknown. Since CRC occurs only in a small subset of alcohol user, alcohol alone may not be sufficient to start the neoplastic process and additional cofactors are required. One such factor is circadian dysrhythmia that is another modern lifestyle habit, shown to be associated with an increased risk of CRC. Further, previous research has shown that disruption of circadian rhythm exacerbates alcohol-induced intestinal inflammation. The Investigator hypothesize that altered circadian rhythms due to "wrong-time" eating (abnormal eating) are an important determinant in alcohol induced mucosal inflammation and carcinogenesis. Our preliminary data supports our hypothesis and shows that abnormal eating patterns accelerate alcohol-induced polyposis in a mouse model of CRC. 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.

Details
Condition Colorectal Cancer
Treatment Alcohol, sigmoidoscopy, Right time eating, Delayed time eating, Optional 24h circadian assessment in the Biological Rhythms lab
Clinical Study IdentifierNCT03955510
SponsorRush University Medical Center
Last Modified on13 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults (greater than 21 years old)
Have had advanced tubular adenoma within the last year

Exclusion Criteria

Asian ethnicity (Due to common polymorphisms of enzymes involved in alcohol metabolism)
Does not drink alcohol
Alcohol use disorder/Alcohol Abuse
A known genetic predisposition to colorectal cancer (FAP, Lynch syndrome)
A history of colorectal cancer or inflammatory bowel diseases
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 or necessitate a particular eating pattern (e.g., uncontrolled
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)
diabetes, eating disorders)
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)
Any active cancer
Inability to sign an informed consent
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