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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different eating and drinking habits might affect the risk of developing colorectal cancer. Participants will try various combinations of meal timing and alcohol consumption over several weeks to observe how these habits influence the body's natural rhythms and gut health. It is ideal for individuals who have had advanced tubular adenoma (a type of colon polyp) in the past year and do not have certain health conditions that could interfere with the study. The goal is to better understand how lifestyle choices impact cancer risk, potentially helping to identify individuals at higher risk in the future. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to improved prevention strategies for colorectal cancer.

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.

What prior data suggests that these eating patterns and alcohol consumption are safe for participants?

Research shows that meal timing can affect the risk of colorectal cancer. Eating meals during the day might lower this risk, while eating later could increase the chance of developing certain colorectal growths.

Heavy alcohol consumption is a known risk factor for colorectal cancer. The effects of moderate drinking are less clear, but some studies suggest it might not be completely safe.

Adjusting meal times and moderating alcohol intake are generally safe and common lifestyle changes. However, even moderate alcohol consumption carries some health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the timing of eating and moderate alcohol consumption might influence colorectal cancer outcomes. Unlike standard treatments that focus on medication or surgical interventions, this trial investigates lifestyle changes as a potential factor in cancer management. By examining “right time” eating and “delayed time” eating patterns, both with and without alcohol, the trial aims to uncover whether these daily habits could play a role in cancer prevention or progression. This is particularly intriguing because it suggests a non-invasive approach that could complement existing treatment options.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

This trial will compare "right-time eating" and "delayed-time eating" with and without alcohol consumption. Research has shown that eating meals at regular times earlier in the day, known as "right-time eating," may help maintain colon health and lower cancer risk. In contrast, eating meals later, called "delayed-time eating," can disrupt the body's natural rhythms and may worsen alcohol's harmful effects on the colon. Some studies suggest that eating at the right times might protect against colon issues related to alcohol. However, research on the effects of eating later continues. Overall, maintaining a regular meal schedule could benefit colon health, especially when combined with limited alcohol intake. ^{6 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. withpower.com withpower.com/trial/phase-carcinogenesis-6-2016-93195

Right Time Eating and Delayed Time Eating for Colorectal ... Trial Overview The study tests how 'right-time' and 'delayed-time' eating patterns combined with alcohol consumption affect susceptibility to colorectal cancer.

2. withpower.com withpower.com/clinical-trials/for-prediabetes

Top Prediabetes Clinical Trials | Power Right Time Eating and Delayed Time Eating for Colorectal Cancer. Unbiased ResultsWe believe in providing patients with all the options. Your Data Stays Your ...

3. withpower.com withpower.com/trial/phase-3-crohn-disease-8-2021-5ac2d

Vedolizumab for Crohn's Disease Right Time Eating and Delayed Time Eating for Colorectal Cancer · Genomic Sequencing for Genetic Disorders · Triple Therapy for Chronic Lymphocytic Leukemia.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/10/NCT03955510/ICF_001.pdf

Cover Page “Right-time eating” means breakfast before 8am ... colorectal cancer. Additionally, the knowledge ... collect follow-up data on you. If follow-up ...

5. researchgate.net researchgate.net/publication/337002396_Abnormal_Eating_Patterns_Cause_Circadian_Disruption_and_Promote_Alcohol-Associated_Colon_Carcinogenesis

Abnormal Eating Patterns Cause Circadian Disruption and ... ileum. 24. Mice were exposed to WTE or right-time eating. (RTE) regimens, either alcohol-treated (RTE þalcohol or. WTE þalcohol) or water-treated (RTE þwater ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6819207/

Meta-analysis of 16 studies of the association of alcohol with ... While heavy alcohol consumption is an established risk factor for colorectal cancer (CRC) (3–12), associations at moderate levels of consumption are unclear.

7. academic.oup.com academic.oup.com/jnci/article/117/5/971/7926885

Drinking pattern and time lag of alcohol consumption with ... Our data implies limited benefits for CRC prevention within 10 years after quitting or reducing alcohol consumption. A case-control study found the duration of ...

8. who.int who.int/europe/news/item/04-01-2023-no-level-of-alcohol-consumption-is-safe-for-our-health

No level of alcohol consumption is safe for our health Alcohol causes at least seven types of cancer, including the most common cancer types, such as bowel cancer and female breast cancer. Ethanol ( ...

9. hhs.gov hhs.gov/sites/default/files/oash-alcohol-cancer-risk.pdf

Alcohol and Cancer Risk 2024 For certain cancers, like breast, mouth, and throat cancers, evidence shows that this risk may start to increase around one or fewer drinks per day. This ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523041783

Alcohol consumption and survival of colorectal cancer ... Prediagnostic alcohol abstaining and heavy drinking were associated with poorer survival after a CRC diagnosis than light drinking.