Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis
AFT
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Jul 2016
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2016
CompletedFirst Submitted
Initial submission to the registry
April 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedOctober 28, 2025
October 1, 2025
6.8 years
April 8, 2019
October 24, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Mucosal Outcome
Sigmoid mucosal biopsy specimens are collected at baseline and at the end of each intervention week. Using gene expression analysis (RNA seq), impact of our intervention on sigmoid mucosal samples, with regard to the mucosal immune response will be assessed. This will be assessed by % change in immune expression. Tissue staining will be used to measure the effect of our interventions on markers of colonic neoplastic process including epithelial proliferation and apoptosis. The effect will be assessed by % changes in proliferation and apoptosis rate in the tissue.
Through study completion and data analysis in 3 years (2022)
Circadian Outcome
Impact of our treatments on circadian read outs will be assessed by using a wrist actigraphy in which activity data to calculate phase assessment (hr units) and sleep indexes including {sleep duration, wake after sleep onset (in minutes), total sleep time (in minutes), and sleep percentage} will be measured. If the subject is interested, our in house circadian lab measurements (activity data and urine melatonin as described plus buccal circadian gene expression) will be available to complement the aforementioned circadian measures. To this end , subjects will enter the Biological Rhythms Research Lab after each week of the intervention period for 24h for assessments of central circadian rhythms (hourly salivary melatonin) and peripheral clock genes of the digestive tract from mucosal cells taken from buccal swaps once every 2h (12 time points). Percent change in expression level of the genes will be compared between groups.
Through study completion and data analysis in 3 years (2022)
Microbiota Outcome
Microbial DNA will be isolated from the stool and the biopsy material Effects of the interventions in this study on the gut microbial compositions will be identified by using 16s microbial analysis.
Through study completion and data analysis in 3 years (2022)
Secondary Outcomes (4)
Food time and Sleep time Outcomes
Through study completion and data analysis in 3 years (2022)
Gastrointestinal symptoms
Through study completion and data analysis in 3 years (2022)
A 24h food recall
Through study completion and data analysis in 3 years (2022)
Establish the link and interaction of delayed eating, and alcohol intake on risks associated with colon cancer.
Through study completion and data analysis in 3 years (2022)
Study Arms (4)
"Right-time eating" / no alcohol
OTHER"Right-time eating" means breakfast before 8am, lunch before 1 pm and dinner before 6pm. Subjects will be asked to stick to this eating schedule for 1 week. Subjects will be asked to not drink alcohol for 1 week. Subjects will randomly be assigned to each eating pattern during the study period.
"Right-time eating" / with alcohol
OTHER"Right-time eating" means breakfast before 8am, lunch before 1 pm and dinner before 6pm. Subjects will be asked to stick to this eating schedule for 1 week. Subjects will randomly be assigned to each eating pattern during the study period. Moderate alcohol drinking means 0.3-0.5 g/kg alcohol daily, which will be not more than 2 glasses of wine depending on subject's weight. Alcohol will always be consumed in the evening with food or after food (e.g., dinner). The timing of alcohol consumption will be consistent for each individual. Subjects will be provided with red wine for the 1 alcohol intervention week. The order of conditions will be random.
"Delayed-eating" / no alcohol
OTHER"Delayed-eating" means eating each meal 3 hours later than the "Right-time eating."Subjects will be asked to stick to this eating schedule for 1 week. Subjects will randomly be assigned to each eating pattern during the study period. Subjects will be asked to not drink alcohol for 1 week.
"Delayed-eating" / with alcohol
OTHER"Delayed-eating" means eating each meal 3 hours later than the "Right-time eating."Subjects will be asked to stick to this eating schedule for 1 week. Subjects will randomly be assigned to each eating pattern during the study period. Moderate alcohol drinking means 0.3-0.5 g/kg alcohol daily, which will be not more than 2 glasses of wine depending on subject's weight. Alcohol will always be consumed in the evening with food or after food (e.g., dinner). The timing of alcohol consumption will be consistent for each individual. Subjects will be provided with red wine for the 1 alcohol intervention week. The order of conditions will be random.
Interventions
"Right-time eating" means breakfast before 8am, lunch before 1 pm and dinner before 6pm. Subjects will be asked to stick to this eating schedule for 1 week. Subjects will randomly be assigned to each eating pattern during the study period. Each subject will be required to do this intervention twice during the study period. One time they will have right time eating with alcohol , the second time the will have this intervention without alcohol.
"Delayed-eating" means eating each meal 3 hours later than the "Right-time eating."Subjects will be asked to stick to this eating schedule for 1 week. Subjects will randomly be assigned to each eating pattern during the study period. Each subject will be required to do this intervention twice during the study period. One time they will have delayed time eating with alcohol , the second time the will have this intervention without alcohol.
Subjects will undergo unprepped sigmoidoscopy to collect tissue and stool sample at each intervention visits (visit 2, 3, 4, and 5). Flexible sigmoidoscopy will not require any colon cleansing and it will be very limited to the most distal (closest to the end of the anus) 20 centimeters (approximately 8 inches) of the colon and thus will be far less uncomfortable than the routine flexible sigmoidoscopy.
Subjects may choose to participate in the 24 hour circadian assessment in the Biological Rhythms Research Lab. During this assessment, a saliva sample will be taken every hour, a mouth swab will be done every 2 hours, and rectal swab will be done twice (every 12 hours). Subjects will be kept awake in dim light on a recliner chair. Subjects can watch a television with dimmed light. Subjects will be provided with food and drink during the assessment. If subjects choose this intervention they will be asked to complete 4 assessment during the course of the study period.
Moderate alcohol drinking means 0.5 g/kg alcohol daily, which will be not more than 2 glasses of wine depending on subject's weight. Alcohol will always be consumed in the evening with food or after food (e.g., dinner). The timing of alcohol consumption will be consistent for each individual. Subjects will be provided with red wine for the 2 alcohol intervention weeks. The order of conditions will be random.
Eligibility Criteria
You may qualify if:
- Adults (greater than 21 years old)
- Have had advanced tubular adenoma within the last year
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Keshavarzian, MD
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 8, 2019
First Posted
May 20, 2019
Study Start
July 31, 2016
Primary Completion
May 31, 2023
Study Completion
May 1, 2026
Last Updated
October 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
No identifying information will be shared with other researchers