Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer

Completed · Not applicable

Conditions studied: Obesity, Colorectal Cancer, Microbial Colonization, Time Restricted Feeding, Stress, Psychological

In brief

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-related markers. The main question\[s\] it aims to answer are: * Is it feasible and acceptable to conduct 8-week remote interventions of TRE, MBSR, and combined TRE+MBSR among young adults with excess adiposity and moderate-to-severe perceived stress? * Will participants in the combined group lose more body weight and reduce their stress levels than those in the remaining groups? * Will participants in the combined group experience better body composition changes and improve their cardiometabolic health compared to those in the remaining groups? * Will participants in the combined group exhibit changes in the microbiome compared to those in the remaining groups? Participants will: * Complete 8 weeks of a TRE intervention * Complete 8 weeks of a remote MBSR intervention Researchers will compare 1. TRE alone; 2. MBSR alone; 3. TRE + MBSR; and 4. Control to see if the study is feasible and acceptable; to see if individuals lose body weight; to see if individual stress levels reduce; to see changes in the microbiome.

Key facts

Study ID

NCT06022887

Run by

Lisa Tussing-Humphreys

People needed

43

Starts

2023-10-18

Expected to finish

2024-07-24

Last updated by the study team

2024-08-21

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Applied Health Sciences Building - University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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