Colorectal CancerAFTNCT03955510
Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis
A study testing Right time eating, Delayed time eating and Sigmoidoscopy in people with Colorectal Cancer, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Right time eating, Delayed time eating and Sigmoidoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2016to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (greater than 21 years old)
- Have had advanced tubular adenoma within the last year
Who cannot join
- 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
Show all 22Show fewer
- 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 diabetes, eating disorders)
- 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)
- Any active cancer
- Inability to sign an informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the detailed 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.
- Conditions
- Colorectal Cancer
- Being tested
- Right time eating, Delayed time eating, Sigmoidoscopy, Optional 24h circadian assessment in the Biological Rhythms lab, Alcohol
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right time eatingOther
"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 time eatingOther
"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.
SigmoidoscopyProcedure or surgery
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.
Optional 24h circadian assessment in the Biological Rhythms labProcedure or surgery
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.
AlcoholOther
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.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: Other: Right time eating; Procedure: Sigmoidoscopy; Procedure: Optional 24h circadian assessment in the Biological Rhythms lab |
| "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. Receives: Other: Right time eating; Procedure: Sigmoidoscopy; Procedure: Optional 24h circadian assessment in the Biological Rhythms lab; Other: Alcohol |
| "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. Receives: Other: Delayed time eating; Procedure: Sigmoidoscopy; Procedure: Optional 24h circadian assessment in the Biological Rhythms lab |
| "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. Receives: Other: Delayed time eating; Procedure: Sigmoidoscopy; Procedure: Optional 24h circadian assessment in the Biological Rhythms lab; Other: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through study completion and data analysis in 3 years (2022)
Secondary outcomes (4)
Food time and Sleep time Outcomes
Eating and sleeping time will be recorded by having participants complete the weekly Food Timing/Sleep Questionnaire where participants record their meal timings and sleep hours throughout the period of the study. Variation in meal and sleep time in weekdays and weekends (in hour unit) will be compared among conditions.
Measured: Through study completion and data analysis in 3 years (2022)
Gastrointestinal symptoms
Subjects may report their experience after each intervention. For this, we will provide participants a questionnaire about common gastrointestinal symptoms that they have experienced within the past 7 days. Participants will scale the severity of their symptoms from 0 - 10 (1 being very mild, 10 being very severe and 0 if no symptom experienced).
Measured: Through study completion and data analysis in 3 years (2022)
A 24h food recall
24h food recall will be completed by participants using Automated Self-Administered 24-Hour at baseline and once during each intervention.
Measured: 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.
Effects of delayed eating with alcohol on circadian outcome, microbiota and mucosal markers of colon carcinogenesis will be assessed by analyzing neoplastic mucosal markers (via tissue staining) as well as gene expression.
Measured: Through study completion and data analysis in 3 years (2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start31 Jul 2016
- Primary completion31 May 2023
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Keshavarzian, Rush University Medical Center
- Investigators
- Ali Keshavarzian, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955510
- Sponsor's protocol ID
- 16051904
- Acronym
- AFT
- Status last verified
- Sep 2026
- First submitted
- 8 Apr 2019
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifying information will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis
- ClinicalTrials.gov ID
- NCT03955510
- Acronym / sponsor ID
- AFT / 16051904
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 31 Jul 2016 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| "Right-time eating" / no alcohol | Other | Other: Right time eating, Procedure: Sigmoidoscopy, Procedure: Optional 24h circadian assessment in the Biological Rhythms lab"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 | Other: Right time eating, Procedure: Sigmoidoscopy, Procedure: Optional 24h circadian assessment in the Biological Rhythms lab, Other: Alcohol"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 | Other: Delayed time eating, Procedure: Sigmoidoscopy, Procedure: Optional 24h circadian assessment in the Biological Rhythms lab"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 | Other: Delayed time eating, Procedure: Sigmoidoscopy, Procedure: Optional 24h circadian assessment in the Biological Rhythms lab, Other: 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. 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (greater than 21 years old)
- Have had advanced tubular adenoma within the last year
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right time eating"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. | Other | "Right-time eating" / no alcohol, "Right-time eating" / with alcohol |
| Delayed time eating"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. | Other | "Delayed-eating" / no alcohol, "Delayed-eating" / with alcohol |
| SigmoidoscopySubjects 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. | Procedure or surgery | "Delayed-eating" / no alcohol, "Delayed-eating" / with alcohol, "Right-time eating" / no alcohol, "Right-time eating" / with alcohol |
| Optional 24h circadian assessment in the Biological Rhythms labSubjects 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. | Procedure or surgery | "Delayed-eating" / no alcohol, "Delayed-eating" / with alcohol, "Right-time eating" / no alcohol, "Right-time eating" / with alcohol |
| AlcoholModerate 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. | Other | "Delayed-eating" / with alcohol, "Right-time eating" / with alcohol |
Primary outcome
Mucosal Outcome
Time frame: Through study completion and data analysis in 3 years (2022)
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.
Circadian Outcome
Time frame: Through study completion and data analysis in 3 years (2022)
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.
Microbiota Outcome
Time frame: Through study completion and data analysis in 3 years (2022)
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.
4 secondary outcomes
Food time and Sleep time Outcomes
Time frame: Through study completion and data analysis in 3 years (2022)
Gastrointestinal symptoms
Time frame: Through study completion and data analysis in 3 years (2022)
A 24h food recall
Time frame: 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.
Time frame: Through study completion and data analysis in 3 years (2022)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. No identifying information will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Keshavarzian, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right time eating, Delayed time eating and Sigmoidoscopy in people with Colorectal Cancer, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal Outcome (time frame: Through study completion and data analysis in 3 years (2022)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.