Clinical trial: NCT03955510
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?

There may be no direct benefit to you for participating in this study. However, if you were found to have the most dramatic responses to alcohol and delayed food timing you could be advised to follow a circadian (time) -friendly based food timing to prevent colorectal cancer. Additionally, the knowledge from this study will help shape the future recommendation for colorectal cancer prevention.
Clinical trial: NCT03955510
Section: Confidentiality
Subsections: What About Confidentiality Of Your Information?

Records of participation in this research study will be maintained and kept confidential as required by law. Unique assigned identification numbers will be used along with your initials for identifying your written information. Any records identifying you will also be kept confidential to the extent permitted by applicable laws and/or regulations. The researchers are HIPAA (privacy) trained and will abide by HIPAA rules. Your study information will be kept under lock at the Section of Digestive Diseases Offices at Rush University in Suites 222, 224 or 206, under double lock. Your study questionnaires will only contain your unique study subject number. The study database is secured in an electronic database (also known as a firewall) at Rush, and the Rush system is compliant with HIPAA. This database will be password protected by research personnel and will have no identifying information. If you withdraw from this study, the data already collected from may not be removed from the study records. The study doctor and/or study team may ask you whether they can continue to collect follow-up data on you. If follow-up information will be requested, you will be asked to sign a separate consent form before this information can be collected. In order to conduct the study, the study doctor, Dr. Faraz Bishehsari, will use and share personal health information about you. This includes information already in your medical record, as well as information created or collected during the study. Examples of the information that may be shared include your medical history, physical exam and laboratory test results. The study doctor will use this information about you to complete this research. Your identity will not be revealed on any report, publication, or at scientific meetings. Confidentiality and disclosure of your personal information is further described in the attachment to this form. The attachment is titled HIPAA Authorization to Share Personal Health Information in Research (2 pages). The Rush Institutional Review Board (IRB) will have access to your files as they pertain to this research study. The IRB is a special committee that reviews new and ongoing human research studies to check that the rules and regulations are followed regarding the protection of the rights and welfare of human subjects.
Clinical trial: NCT03955510
Section: Duration of Study Involvement
Subsections: How Long Will You Be In The Study? You Will Be In The Study For 8 Weeks.

You may be removed from this study without your consent. Possible reasons may be that the study doctor decides that continued participation in the study will be harmful to you, you will need a treatment not allowed on the study, you are unable to follow the schedule as directed, or the study is canceled. If you decide to participate, you are free to withdraw your consent and discontinue participation at any time without prejudice. If you sign the GI Tissue Repository consent in addition to this consent, then any data that has been collected and any remaining samples that are untested will not be discarded. If you choose to withdraw at any time during the study, please contact the principal investigator (study doctor), Dr. Faraz Bishehsari at 312-942-5861.
Clinical trial: NCT03955510
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Possible Risks Of The Study?|Are There Any Anticipated Pregnancy Risks?|What Are The Costs Of Your Participation In This Study? All Costs That Are Part Of This Research Study Will Be Free Of Charge.|What Happens If You Experience A Research Related Injury?|What Happens If You Need Emergency Care?

1) There are minimal risks of the study, which are mainly related to discomfort with unprepped sigmoidoscopy. For this procedure, a doctor will look at part of your colon in order to collect tissue samples from the colon. There is a risk of bleeding when tissue samples are taken with any endoscopic procedure. If bleeding happens, it will usually stop by itself and does not usually require hospitalization, transfusion (administration of blood) or other interventions. There is also a risk of a tiny tear (perforation) and infection in your colon with sigmoidoscopy and tissue sample collection. This is extremely rare but a possible complication. If an infection or tiny tear occurs, you may experience pain and fever. If you experience an infection and/or tiny tear and fever, you should contact the study doctor, Dr. Faraz Bishehsari, immediately, by calling 312-942-5861. In order to minimize these small risks of complication, all procedures will be done by Dr. Faraz Bishehsari.  
2) Being awake for 24 hours cause fatigue. We recommend not operating heavy machinery or driving until you get enough sleep. We recommend that you have your family or friend drive you, or take other transportation (such as public transportation). Giving rectal and mouth samples every 12 and 2 hours respectively can be uncomfortable. Our technicians are trained and will make this process as simple as possible.  
3) You may choose to collect urine sample. You may experience emotional stress related to handling with your own urine. Mishandling urine can lead to infections, however, a safe hand washing technique will be taught and reduce this risk.  
4) Alcohol can aggravate certain medical conditions and some medications can have drug interactions with alcohol. You should inform any medical conditions you have and medications that you take or plan to take (both prescription and over the counter) to the study doctor to prevent any harmful interactions by consuming alcohol. During the weeks of alcohol consumption, do not do things that require skill, coordination, and alertness after drinking, such as driving a car or operating hazardous equipment.
5) In addition, exposure to moderate alcohol intake and 3-hour delay in food timing are possible risks. According to the "Dietary Guidelines for Americans 2015-2020," U.S. Department of Health and Human Services and U.S. Department of Agriculture, recommended alcohol intake is up to 1 drink per day for women and up to 2 drinks per day for men. Depending on your weight, you may be asked to consume up to 2 to 4 times more of what is generally recommended for total of two weeks during the entire study duration. The risks of this level of drinking are fully described in the brochure "Beyond Hangovers." Key risks associated with consumption of moderate drinking may include interaction with certain medications, sleep disruption, and clouding of judgment. In this study, we do not recommend participating in our study and drinking alcohol if you don't usually drink; we advise against higher doses of alcohol, and limit the duration of moderate alcohol consumption to one week (the study duration for each intervention). We will further minimize any potential risks that could be associated with one week of moderate dose of alcohol drinking by going over your medications prior to study; if any major interaction is identified you will not be recruited. Moreover, prior to each visit before the study intervention, we will review with you any new medications or conditions that you may have developed and provide you specific instruction on consumption of alcohol. If new conditions or medications have potential dangerous interaction with alcohol, you will be excluded from the study.

Women If you are pregnant, breastfeeding, or planning to be pregnant, you cannot take part in this study. You are responsible for using an effective birth control method such as birth control pills, barrier method (such as condoms or diaphragms), intrauterine device (IUD), hormone implants or surgical sterility while you are taking part in this study. If you become pregnant, you must notify the study doctor immediately.

If you are driving to Rush, we will provide you with parking stickers for the Rush parking garage. We cannot reimburse you for valet parking or for cab fare to and from Rush. We will provide a paid parking sticker at your visit good only for parking at Rush University Medical Center. If you take public transportation to Rush (such as CTA) we will reimburse you for the round trip fare up to a maximum of $10.

If you experience any injury or illness as a direct result of your participation in this research study, immediate treatment will be provided. However, the cost of that treatment will be billed to you or your insurance company. Please check with your insurance company regarding coverage. If you have any medical problems during the study, please contact the study doctor. He or she will explain your treatment options to you and/or help you find a place to get treatment. Rush University Medical Center has no program for financial compensation or other forms of compensation for injuries which you may incur as a result of participation in this study.

If you need emergency care while you are participating in this study, it is important that you tell emergency personnel of your participation in this study and notify the study doctor as soon as possible.
Clinical trial: NCT03955510
Section: Procedures
Subsections: What Will You Be Asked To Do? Screening Visit (Study Visit 1):|Intervention Visits (Study Visit 2, 3, 4, And 5)|Flexible Sigmoidoscopy|Circadian (Sleep Cycle) Assessment

After you have reviewed this information sheet and signed it, we will check to see if you are eligible for this study by answering questionnaires and having a physical exam. We will ask you to complete a questionnaire related to demographic information (such as age, race, sex, occupation, education) and medical history. You will then complete the weekly Food Timing/Sleep Questionnaire and online 24-hour food recall to gather information about timing of food intake and diet. You will also be interviewed by the clinical coordinator with the Lifetime Drinking History assessment tool to evaluate your alcohol drinking history. A study doctor or assistant will do a physical exam and take your vitals (such as height, weight, waist circumference, and blood pressure). If you are eligible, you will be given an actigraphy, an electronic device which monitors your rest/activity cycles during the study period. You will be randomly assigned to one of the interventions. You will then be told to eat normally with no alcohol for 1 week before you start the first intervention week. You will also be asked to complete the daily Food Timing/Sleeping Questionnaire until visit 2. As an option, you can take a picture of each meal/snack and email to the study coordinator and only complete the sleep questions in the Food Timing/Sleep Questionnaire.

You will come in for your visits 2, 3, 4, and 5 after completing each intervention week. You will experience all four conditions of (1) "right-time eating" / no alcohol, (2) "right-time eating" / with alcohol, (3) "delayed-eating" / no alcohol, (4) "delayed-eating" / with alcohol at the end of the study. "Right-time eating" means breakfast before 8am, lunch before 1 pm, and dinner before 6pm. "Delayed-eating" means eating each meal 3 hours later than the "Right-time eating." Moderate alcohol drinking means 0.5 g/kg alcohol daily, which will be not more than 3-4 glasses of wine depending on your 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. You will be provided with red wine for your 2 alcohol intervention weeks. The order of conditions will be random. After each week of intervention, you will come in for an intervention visit, then you will have one week of wash-out period (+/- 2 days) before starting another intervention week. Wash-out period means that you will eat as you normally would during this time. During the intervention weeks, you will be asked to complete two online-24 hour food recalls for one week day and one weekend day. You will also be asked to complete the daily Food Timing/Sleep Questionnaire between each visit. As an option, you can take a picture of each meal/snack and email to the study coordinator and only complete the sleep questions in the Food Timing/Sleep Questionnaire. At each intervention visit, you will complete the weekly Food Timing/Sleep Questionnaire, a dietitian will ask you to do a 24-hour food recall, and you will undergo an unprepped sigmoidoscopy. If we were unable to collect enough stool during sigmoidoscopy, we will ask you to collect your stool at home and bring the next day.

You will undergo unprepped sigmoidoscopy to collect tissue and stool sample at each intervention visits (visit 2, 3, 4, and 5). Flexible sigmoidoscopy will not require any colon cleansing and it will be very limited to the most distal (closest to the end of the anus) 20 centimeters (approximately 8 inches) of your colon and thus will be far less uncomfortable than the routine flexible sigmoidoscopy. This type of procedure is not associated with much discomfort. Most patients either experience no discomfort or minimal bloating. During the flexible sigmoidoscopy, you will not receive any sedation (agent that makes you sleepy) or anesthesia (numbing agent). This type of procedure occurs routinely without any sedation or anesthesia and is completed in less than five minutes. You will not require any assistance in getting home. Sigmoidoscopy will happen in the morning on a mid-week day, and be kept 3 of 9

At the end of each intervention week, you will have 3 choices on how to do the circadian assessment. Once you choose one type of assessment, you will be asked to keep the same chosen assessment for the entire study. You will be performing the assessments 4 times. Your choices are the following:  
1. You will undergo a 24 hour assessment in the Biological Rhythms Research Lab. During this assessment, a saliva sample will be taken every hour, a mouth swab will be done every 2 hours, and rectal swab will be done twice (every 12 hours). You will be kept awake in dim light on a recliner chair. You can watch a television with dimmed light, or talk to each other. You will be provided with food and drink during the assessment. Driving after staying awake for 24 hours can be dangerous. We recommend to have your family or friend drive you, or to take other transportation (such as public transportation) to arrive and to leave after the assessment.  
2. In addition to the 24 hour assessment explained above, you will collect your urine first thing in the morning of your visit in a jug provided by the study staff, prior to the intervention visit at home and will bring the jug with you to your visit. Voids from additional nighttime bathroom trips should be collected in the same jug and kept in the refrigerator Instruction on how to collect the urine will be provided.  
3. You will only collect your urine first thing in the morning of your visit in a jug provided by the study staff, prior to the intervention visit at home and will bring the jug with you to your visit. Voids from additional nighttime bathroom trips should be collected in the same jug and kept in the refrigerator Instruction on how to collect the urine will be provided.  
| Week #                                                                                                                      | 1       | 2         | 3       | 4         | 5       | 6         | 7   | 8         | Final  Visit   |
|-----------------------------------------------------------------------------------------------------------------------------|---------|-----------|---------|-----------|---------|-----------|-----|-----------|----------------|
| Visit #                                                                                                                     | Visit 1 | Visit 2   | Visit 3 | Visit 4   | Visit 5 |           |     |           |                |
| Intervention                                                                                                                | Normal  | Condition | Washout**         | Condition | Washout**         | Condition | Washout**     | Condition |                |
| Eating                                                                                                                      | 1*      | 2*        | 3*      | 4*        |         |           |     |           |                |
| Sigmoidoscopy                                                                                                               | #1      | #2        | #3      | #4        |         |           |     |           |                |
| Circadian                                                                                                                   | #1      | #2        | #3      | #4        |         |           |     |           |                |
| Assessment+ *Intervention will be one of the following conditions in random (by chance) order: (1) "right-time eating" / no |         |           |         |           |         |           |     |           |                |  
Table 1. Study Timeline example
*Intervention will be one of the following conditions in random (by chance) order: (1) "right-time eating" / no alcohol, (2) "right-time eating" / with alcohol, (3) "delayed-eating" / no alcohol, (4) "delayed-eating" / with alcohol ** You will eat as you normally would during the wash-out period + Subject can choose from 3 options: 1. Only 24 hour circadian assessment, 2. 24 hour circadian assessment and urine collection, and 3. Only urine collection
Clinical trial: NCT03955510
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

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.
Clinical trial: NCT03955510
Section: Voluntary Participation
Subsections: Why Are You Being Invited To Participate In This Study?

You are being asked to take part in this study because you have had advanced tubular adenoma which are considered pre-cancer growths found during a colon (large bowel) examination within the last year and you have no history of alcohol abuse.