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

Recruiting in Palo Alto (17 mi)

Overseen byFaraz Bishehsari, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rush University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am over 21 years old.

I had a serious type of polyp in my colon or rectum in the last year.

Exclusion Criteria

I have Restless Leg Syndrome.

Does not drink alcohol

Asian ethnicity (Due to common polymorphisms of enzymes involved in alcohol metabolism)

+19 more

Participant Groups

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.

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