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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion and data analysis in 3 years (2022)
Awards & highlights
AFT Trial 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.Check my eligibility
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.See study design
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.
AFT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 21 years old.
Select...
I had a serious type of polyp in my colon or rectum in the last year.
AFT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion and data analysis in 3 years (2022)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion and data analysis in 3 years (2022)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Circadian Outcome
Microbiota Outcome
Mucosal Outcome
Secondary outcome measures
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 moreAFT 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
422 Previous Clinical Trials
163,489 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Restless Leg Syndrome.I am unable to understand or sign the consent form.I have a genetic condition linked to colorectal cancer.I am over 21 years old.I have had colorectal cancer or inflammatory bowel diseases.I have health conditions that could affect my body's internal clock.I am currently hospitalized.I have traveled across more than two time zones in the last week.I had a serious type of polyp in my colon or rectum in the last year.I currently have active cancer.I have long-term kidney problems.I haven't taken melatonin, metoclopramide, psychotropic drugs, or sleep aids in the last 4 weeks.I have cirrhosis.I have an advanced neurological condition like Parkinson's, MS, or epilepsy.I have severe heart failure.I haven't taken antibiotics or pro/prebiotics in the last three months.I have been diagnosed with sleep apnea.
Research Study Groups:
This trial has the following groups:- Group 1: "Delayed-eating" / with alcohol
- Group 2: "Right-time eating" / no alcohol
- Group 3: "Delayed-eating" / no alcohol
- Group 4: "Right-time eating" / with alcohol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are seniors in the fifty-and-over age range admissible for this experiment?
"Patients aged 21 years or older, but not yet 75 are eligible to partake in this medical investigation."
Answered by AI
Are there any available opportunities for individuals to participate in the trial currently?
"Affirmative. The details posted on clinicaltrials.gov confirm that this medical investigation is currently recruiting patients, having been initially advertised in July 2016 and updated as of June 2022. 44 people are needed to take part at one particular site."
Answered by AI
Is it possible for me to participate in this medical study?
"Within the age bracket of 21 to 75, 44 individuals with a history of carcinogenesis are being accepted for this study. Patients must also satisfy other prerequisites such as adulthood and having had advanced tubular adenoma in the last 12 months."
Answered by AI
What are the expected results of this research initiative?
"The primary aim of this clinical investigation, which is anticipated to conclude in 3 years (2022), involves ascertaining the role of microbiota on colon cancer risks. Secondary aims include assessing how eating and sleeping patterns affect outcomes through a Food Timing/Sleep Questionnaire that records meal timings and sleep hours throughout the study period; determining links between delayed meals and alcohol intake with regards to circadian outcome, gut microbiology, and mucosal markers via tissue staining as well as gene expression analysis; lastly participants are required to complete an Automated Self-Administered 24-Hour food recall at baseline and once during each intervention phase."
Answered by AI
How many participants are partaking in this clinical experiment?
"Indeed, the clinicaltrials.gov portal reveals that this study is still accepting volunteers. It was initially published on July 22nd 2016 and most recently modified on June 24th 2022; it seeks 44 individuals across a single site."
Answered by AI
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