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

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.

Sex

All

Minimum age

18 Years

Maximum age

39 Years

Inclusion Criteria:

1. 18-39 years old.
2. BMI 30-49.99 kg/m2.
3. Own and use a smartphone, computer, or tablet with access to the Internet.
4. Score ≥ 14 on the Perceived Stress Score (PSS) at screening.

Exclusion Criteria:

1. Have a personal or family history of EOCRC.
2. Have taken antibiotics in the previous 2 months.
3. Have an inflammatory bowel disease or genetic predisposition to EOCRC or CRC (e.g., Lynch syndrome);.
4. Any cancer diagnosis or cancer treatment in the past 12 months.
5. Consume \>50 grams ethanol daily (approximately 4-5, 12 ounces beers).
6. Use combustible tobacco.
7. Have history of bariatric surgery or bowel resection.
8. Have an active infection.
9. Have type 1 or type 2 diabetes, immunodeficiency/autoimmune disorder, or inflammatory bowel disease.
10. Use fiber or pre-/probiotic supplements \>3 days per week.
11. Currently taking corticosteroids medication - inhaled, topical, or oral in the past 2 months (affects cortisol measures).
12. 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.
13. Females who are pregnant/trying to become pregnant.
14. Have schizophrenia (medication can affect study outcomes).
15. Have an eating window of \<10 hours/day or are currently following an intermittent fasting pattern.
16. Night shift workers (shift passes midnight).
17. Present a history of eating disorder.
18. Currently taking weight loss medication.
19. Illegal drug use in the past month (not marijuana).

• BACKGROUNDSinicrope FA. Increasing Incidence of Early-Onset Colorectal Cancer. N Engl J Med. 2022 Apr 21;386(16):1547-1558. doi: 10.1056/NEJMra2200869. No abstract available. PMID 35443109
• BACKGROUNDDoubeni CA, Major JM, Laiyemo AO, Schootman M, Zauber AG, Hollenbeck AR, Sinha R, Allison J. Contribution of behavioral risk factors and obesity to socioeconomic differences in colorectal cancer incidence. J Natl Cancer Inst. 2012 Sep 19;104(18):1353-62. doi: 10.1093/jnci/djs346. Epub 2012 Sep 5. PMID 22952311
• DERIVEDLima Oliveira M, Cares K, Hamm A, Nadeem S, Bogseth D, Klatkiewicz B, Overhiser T, Elias C, Li Y, Guo R, Oddo VM, Biggers A, Naylor KB, Chen Z, Pezley L, Attre M, Penalver Bernabe B, Gabel K, Sharp LK, Bendinskas K, Webber D, Lockwood MB, Jenkins NDM, Tussing-Humphreys LM. A Remote Time-Restricted Eating and Mindfulness Intervention Addressing Risk Factors Associated with Early-Onset Colorectal Cancer Demonstrates Feasibility and Acceptability among Young Adults: A Randomized Controlled Pilot Trial. Nutr Cancer. 2025;77(10):1142-1161. doi: 10.1080/01635581.2025.2557642. Epub 2025 Sep 9. PMID 40924443