Right Time Eating and Delayed Time Eating for Colorectal Cancer

(AFT Trial)

Overseen By GI Research

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must not be taking: Melatonin, Psychotropics, Hypnotics, others

Disqualifiers: Asian ethnicity, Alcohol abuse, Genetic predisposition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you regularly use medications that affect melatonin, like melatonin supplements, certain anti-nausea drugs, or sleep aids, in the four weeks before the study.

Is the treatment of Right Time Eating and Delayed Time Eating for Colorectal Cancer safe for humans?

The research suggests that alcohol consumption, especially in combination with disrupted eating patterns, may increase the risk of colon cancer and other health issues. However, specific safety data for Right Time Eating and Delayed Time Eating without alcohol is not provided in the studies. ^{1 2 3 4 5}

How does the Right Time Eating and Delayed Time Eating treatment for colorectal cancer differ from other treatments?

This treatment is unique because it focuses on the timing of food intake to potentially influence colorectal cancer pathways, unlike traditional treatments that may focus on medication or surgery. It explores how eating at the right or wrong times can affect the body's internal clock (circadian rhythm) and its interaction with alcohol consumption, which is a known risk factor for colorectal cancer. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Right Time Eating and Delayed Time Eating for Colorectal Cancer?

Research suggests that abnormal food timing can worsen the effects of alcohol on colon cancer pathways, while right-time eating may help maintain a healthier balance in the gut and reduce cancer risk. ^{4 7 8 9 10}

Who Is on the Research Team?

Ali Keshavarzian, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo four different eating and alcohol consumption conditions, each lasting one week, with a wash-out period in between.

8 weeks

Weekly visits for sigmoidoscopy and optional circadian assessments

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol
• Delayed time eating
• Right time eating
• Sigmoidoscopy

Trial Overview 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.

How Is the Trial Designed?

Group I: "Right-time eating" / with alcohol Experimental Treatment 4 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 alcohol Experimental Treatment 3 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 alcohol Experimental Treatment 4 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 alcohol Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Association between alcohol consumption and cancer of the sigmoid colon: observations from a Japanese cohort study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Ethanol calories do not enhance breast cancer in isocalorically fed C3H/Ou mice. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Ethanol promotes intestinal tumorigenesis in the MIN mouse. Multiple intestinal neoplasia. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Enhancement of ethanol induced rectal mucosal hyper regeneration with age in F344 rats. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Abnormal Food Timing Promotes Alcohol-Associated Dysbiosis and Colon Carcinogenesis Pathways. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Abnormal Eating Patterns Cause Circadian Disruption and Promote Alcohol-Associated Colon Carcinogenesis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Alcoholic beverages and adenomatous polyps of the sigmoid colon: a study of male self-defence officials in Japan. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Interaction of alcohol with time of eating on markers of circadian dyssynchrony and colon tissue injury. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A case-control study of alcoholic beverage consumption in relation to risk of cancer of the right colon and rectum in men. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of low-to-moderate ethanol consumption on colonic growth and gene expression in young adult and middle-aged male rats. [2021]