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Right Time Eating and Delayed Time Eating for Colorectal Cancer (AFT Trial)

N/A
Waitlist Available
Led By Faraz Bishehsari, MD, PhD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults (greater than 21 years old)
Have had advanced tubular adenoma within the last year
Must not have
Restless Leg Syndrome
Inability to sign an informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion and data analysis in 3 years (2022)
Awards & highlights

Summary

This trial aims to study the impact of Western lifestyle on colorectal cancer susceptibility.

Who is the study for?
This trial is for adults over 21 who've had advanced tubular adenoma in the past year. It's not for those with sleep apnea, alcohol disorders, genetic predispositions to colorectal cancer, inflammatory bowel diseases, or conditions affecting the circadian system like chronic renal failure or night shift work.
What is being tested?
The study tests how 'right-time' and 'delayed-time' eating patterns combined with alcohol consumption affect susceptibility to colorectal cancer. Participants will try four different conditions involving these variables and undergo sigmoidoscopies and optional circadian assessments.
What are the potential side effects?
Potential side effects may include discomfort from sigmoidoscopy without sedation such as bleeding or perforation risks. Hourly saliva collection and rectal sampling might cause minor discomfort. Alcohol intake could have typical effects like intoxication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 21 years old.
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I had a serious type of polyp in my colon or rectum in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Restless Leg Syndrome.
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I am unable to understand or sign the consent form.
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I have a genetic condition linked to colorectal cancer.
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I have had colorectal cancer or inflammatory bowel diseases.
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I am currently hospitalized.
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I have traveled across more than two time zones in the last week.
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I currently have active cancer.
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I have long-term kidney problems.
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I have cirrhosis.
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I have an advanced neurological condition like Parkinson's, MS, or epilepsy.
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I have severe heart failure.
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I have been diagnosed with sleep apnea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion and data analysis in 3 years (2022)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion and data analysis in 3 years (2022) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Circadian Outcome
Microbiota Outcome
Mucosal Outcome
Secondary study objectives
A 24h food recall
Establish the link and interaction of delayed eating, and alcohol intake on risks associated with colon cancer.
Food time and Sleep time Outcomes
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: "Right-time eating" / with alcoholExperimental Treatment4 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. 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.
Group II: "Right-time eating" / no alcoholExperimental Treatment3 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 be asked to not drink alcohol for 1 week. Subjects will randomly be assigned to each eating pattern during the study period.
Group III: "Delayed-eating" / with alcoholExperimental Treatment4 Interventions
"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.
Group IV: "Delayed-eating" / no alcoholExperimental Treatment3 Interventions
"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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sigmoidoscopy
2007
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
431 Previous Clinical Trials
158,389 Total Patients Enrolled
Faraz Bishehsari, MD, PhD5.010 ReviewsPrincipal Investigator - Rush University Medical Center
Rush University Medical Center
5Patient Review
Dr. Bishehsari is an excellent physician. He took the time to review my entire physical history and work with me to find a solution that fit my needs. Thank you!

Media Library

"Delayed-eating" / with alcohol Clinical Trial Eligibility Overview. Trial Name: NCT03955510 — N/A
Colorectal Cancer Research Study Groups: "Delayed-eating" / with alcohol, "Right-time eating" / no alcohol, "Delayed-eating" / no alcohol, "Right-time eating" / with alcohol
Colorectal Cancer Clinical Trial 2023: "Delayed-eating" / with alcohol Highlights & Side Effects. Trial Name: NCT03955510 — N/A
"Delayed-eating" / with alcohol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03955510 — N/A
~1 spots leftby Sep 2025
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