Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||21 Years and Over|
Inclusion Criteria:1. Adults (greater than 21 years old) 2. Have had advanced tubular adenoma within the last year
Exclusion Criteria:1. Asian ethnicity (Due to common polymorphisms of enzymes involved in alcohol metabolism) 2. Does not drink alcohol 3. Alcohol use disorder/Alcohol Abuse 4. A known genetic predisposition to colorectal cancer (FAP, Lynch syndrome) 5. A history of colorectal cancer or inflammatory bowel diseases 6. Presence of comorbidities that might affect the circadian system 1. Chronic renal failure 2. Cirrhosis 3. Advanced neurological conditions (e.g., Parkinson's, MS, epilepsy) 4. Psychological disorders (e.g., PTSD, major depression) 5. Sleep apnea 6. Restless Leg Syndrome 7. Inpatient Status 8. Advanced cardiac failure 9. Night shift workers with active shift work in the past month 10. Planned shift work that will occur during the study 11. Crossed more than two time zones in the previous week 7. Conditions that alter or necessitate a particular eating pattern (e.g., uncontrolled diabetes, eating disorders) 8. Conditions that alter the microbiota (infection or recent history of antibiotic use within three months, or use of pro/prebiotics within one month prior to recruitment) 9. Regular use of medications that can potentially affect melatonin profiles (e.g., Melatonin, Metoclopramide, Psychotropic medications, Hypnotics during the four weeks prior to the study) 10. Any active cancer 11. Inability to sign an informed consent
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Rush University Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal cancer (CRC) is the second leading cause of cancer mortality in the US. CRC's risk is closely linked to the modern lifestyle. Alcohol is commonly used in our society and is an established risk factor for both pre-cancerous (polyp) and cancerous lesions of the colon. However this knowledge has not been translated to our current risk stratifications for CRC as the process of alcohol-induced carcinogenesis is not predictable. Mucosal inflammation is a well-established mechanism that mediates the effect of alcohol induced tissue injury in the intestine. Inflammation also plays a crucial role in pathogenesis of CRC. Factors that promote a pro-tumorigenic inflammatory state in the setting of alcohol are unknown. Since CRC occurs only in a small subset of alcohol user, alcohol alone may not be sufficient to start the neoplastic process and additional cofactors are required. One such factor is circadian dysrhythmia that is another modern lifestyle habit, shown to be associated with an increased risk of CRC. Further, previous research has shown that disruption of circadian rhythm exacerbates alcohol-induced intestinal inflammation. The Investigator hypothesize that altered circadian rhythms due to "wrong-time" eating (abnormal eating) are an important determinant in alcohol induced mucosal inflammation and carcinogenesis. Our preliminary data supports our hypothesis and shows that abnormal eating patterns accelerate alcohol-induced polyposis in a mouse model of CRC. 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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.