Status:
COMPLETED
Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer
Lead Sponsor:
Lisa Tussing-Humphreys
Collaborating Sponsors:
University of Illinois at Chicago
Conditions:
Obesity
Colorectal Cancer
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the feasibility of remote time-restricted eating (TRE) and mindfulness-based stress reduction (MBSR) interventions and the preliminary effect on EOCRC-re...
Detailed Description
Early onset colorectal cancer (EOCRC) is defined as a diagnosis of colorectal cancer (CRC) in patients younger than 50 years old. The American Cancer Society reported that 12% of all CRC diagnoses as ...
Eligibility Criteria
Inclusion
- 18-39 years old.
- BMI 30-49.99 kg/m2.
- Own and use a smartphone, computer, or tablet with access to the Internet.
- Score ≥ 14 on the Perceived Stress Score (PSS) at screening.
Exclusion
- Have a personal or family history of EOCRC.
- Have taken antibiotics in the previous 2 months.
- Have an inflammatory bowel disease or genetic predisposition to EOCRC or CRC (e.g., Lynch syndrome);.
- Any cancer diagnosis or cancer treatment in the past 12 months.
- Consume \>50 grams ethanol daily (approximately 4-5, 12 ounces beers).
- Use combustible tobacco.
- Have history of bariatric surgery or bowel resection.
- Have an active infection.
- Have type 1 or type 2 diabetes, immunodeficiency/autoimmune disorder, or inflammatory bowel disease.
- Use fiber or pre-/probiotic supplements \>3 days per week.
- Currently taking corticosteroids medication - inhaled, topical, or oral in the past 2 months (affects cortisol measures).
- Are on a weight-loss diet or involved in a formal weight-loss program or are not weight stable for 3 months (+/- 4.5 kg) prior to the study.
- Females who are pregnant/trying to become pregnant.
- Have schizophrenia (medication can affect study outcomes).
- Have an eating window of \<10 hours/day or are currently following an intermittent fasting pattern.
- Night shift workers (shift passes midnight).
- Present a history of eating disorder.
- Currently taking weight loss medication.
- Illegal drug use in the past month (not marijuana).
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06022887
Start Date
October 18 2023
End Date
July 24 2024
Last Update
August 21 2024
Active Locations (1)
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1
Applied Health Sciences Building - University of Illinois at Chicago
Chicago, Illinois, United States, 60612