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ACTIVE NOT RECRUITING NA

Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis

NCT03955510 · View on ClinicalTrials.gov ↗

Study Summary

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 Studied

Interventions

  • OTHER Alcohol
  • PROCEDURE Sigmoidoscopy
  • OTHER Right time eating
  • OTHER Delayed time eating
  • PROCEDURE Optional 24h circadian assessment in the Biological Rhythms lab

Study Locations (1)

Illinois

  • Rush University Medical Center — Chicago

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2016-07-31
Est. Completion 2026-05
Phase NA

Sponsor

Rush University Medical Center

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03955510

The ClinicalTrials.gov registry entry for NCT03955510 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 168 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which Alcohol is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03955510 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03955510 about?

NCT03955510 is a clinical study titled "Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis". 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...

What is the current status of trial NCT03955510?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2016-07-31. Estimated completion is 2026-05.

What conditions does trial NCT03955510 study?

This clinical trial studies the following conditions: Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03955510?

The interventions under investigation include: Alcohol (OTHER), Sigmoidoscopy (PROCEDURE), Right time eating (OTHER), Delayed time eating (OTHER), Optional 24h circadian assessment in the Biological Rhythms lab (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03955510?

This trial is sponsored by Rush University Medical Center, which has 168 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03955510 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial