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.

Increased adiposity and chronic psychosocial stress (CPS) are plausible modifiable contributors of the recent increase in early-onset colorectal cancer (EOCRC). We conducted an 8-week randomized controlled pilot trial evaluating the feasibility and acceptability of time restricted eating (TRE) (daily ad libitum eating between 12-8pm) and Mindfulness ("Mindfulness for Beginners" course from the Calm® app) among young adults. Participants were randomized to the following groups: TRE (n = 10); Mindfulness (n = 11); TRE & Mindfulness (n = 11); or Control (n = 11). Forty-three participants were randomized. Acceptability of the trial was high and attrition rates were low (7%). Participants completed 92% of the Mindfulness course, and 90-92% were adherent to the TRE intervention. PSS decreased significantly within the TRE, Mindfulness, and TRE & Mindfulness arms from pre- to post-intervention, but not within the Control arm. The TRE & Mindfulness arm had improvements in visceral fat mass, fasting insulin, fasting glucose, HOMA-IR, hemoglobin A1c, and fecal calprotectin, pre- to post-intervention, compared to the TRE and Mindfulness arms. This study was feasible and well-accepted. Results were promising for the combined TRE & Mindfulness protocol showing superior improvements in perceived stress, visceral adiposity, cardiometabolic and inflammatory markers. It is important to note the limited generalizability of our sample.