Clinical trial · Interventional
Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alcohol | Other | — | UNRESOLVED |
| Delayed time eating | Other | — | UNRESOLVED |
| Optional 24h circadian assessment in the Biological Rhythms lab | Procedure | — | UNRESOLVED |
| Right time eating | Other | — | UNRESOLVED |
| Sigmoidoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- "Right-time eating" / no alcohol
- description
- "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.
- interventionNames
- Other: Right time eating
- Procedure: Sigmoidoscopy
- Procedure: Optional 24h circadian assessment in the Biological Rhythms lab
- type
- OTHER
- label
- "Right-time eating" / with alcohol
- description
- "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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available