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

Not Applicable

Completed

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

• Registration Number: NCT06022887
• Lead Sponsor: Lisa Tussing-Humphreys

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Inclusion Criteria:<br><br> 1. 18-39 years old.<br><br> 2. BMI 30-49.99 kg/m2.<br><br> 3. Own and use a smartphone, computer, or tablet with access to the Internet.<br><br> 4. Score = 14 on the Perceived Stress Score (PSS) at screening.<br><br>Exclusion Criteria:<br><br> 1. Have a personal or family history of EOCRC.<br><br> 2. Have taken antibiotics in the previous 2 months.<br><br> 3. Have an inflammatory bowel disease or genetic predisposition to EOCRC or CRC (e.g.,<br> Lynch syndrome);.<br><br> 4. Any cancer diagnosis or cancer treatment in the past 12 months.<br><br> 5. Consume >50 grams ethanol daily (approximately 4-5, 12 ounces beers).<br><br> 6. Use combustible tobacco.<br><br> 7. Have history of bariatric surgery or bowel resection.<br><br> 8. Have an active infection.<br><br> 9. Have type 1 or type 2 diabetes, immunodeficiency/autoimmune disorder, or<br> inflammatory bowel disease.<br><br> 10. Use fiber or pre-/probiotic supplements >3 days per week.<br><br> 11. Currently taking corticosteroids medication - inhaled, topical, or oral in the past<br> 2 months (affects cortisol measures).<br><br> 12. Are on a weight-loss diet or involved in a formal weight-loss program or are not<br> weight stable for 3 months (+/- 4.5 kg) prior to the study.<br><br> 13. Females who are pregnant/trying to become pregnant.<br><br> 14. Have schizophrenia (medication can affect study outcomes).<br><br> 15. Have an eating window of <10 hours/day or are currently following an intermittent<br> fasting pattern.<br><br> 16. Night shift workers (shift passes midnight).<br><br> 17. Present a history of eating disorder.<br><br> 18. Currently taking weight loss medication.<br><br> 19. Illegal drug use in the past month (not marijuana).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the study;Acceptability of the study

Secondary Outcome Measures

Name	Time	Method
Hair cortisol;Serum adrenocorticotropic hormone (ACTH);Serum cortisol;Serum norepinephrine;Perceived Stress Scale.;Body fat mass;Body lean mass;Body bone density;Triglycerides;High sensitivity C-reactive protein.;homeostasis model assessment-insulin resistance (HOMA-IR);Microbial Deoxyribonucleic acid (DNA) isolation: 16S on V4 region