- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03955510
Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis (AFT)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: "Right-time eating" / no 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 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" 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.
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. |
Other: "Right-time eating" / with 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.
|
"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.
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.
|
Other: "Delayed-eating" / no 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.
Subjects will be asked to not drink alcohol for 1 week.
|
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.
"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" / with 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.
|
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.
"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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Through study completion and data analysis in 3 years (2022)
|
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. |
Through study completion and data analysis in 3 years (2022)
|
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.
|
Through study completion and data analysis in 3 years (2022)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food time and Sleep time Outcomes
Time Frame: Through study completion and data analysis in 3 years (2022)
|
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.
|
Through study completion and data analysis in 3 years (2022)
|
Gastrointestinal symptoms
Time Frame: Through study completion and data analysis in 3 years (2022)
|
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).
|
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)
|
24h food recall will be completed by participants using Automated Self-Administered 24-Hour at baseline and once during each intervention.
|
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)
|
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.
|
Through study completion and data analysis in 3 years (2022)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Faraz Bishehsari, MD, PhD, Rush University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16051904
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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