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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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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:
Participants will:
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.
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 occurring in individuals younger than 50 years old. Worldwide, a steady increase in EOCRC cases is observed among Westernized countries, which suggests that similar risk factors and exposures within these developed countries are contributors to EOCRC. In particular, increased adiposity from an early age that persists through adulthood and chronic psychosocial stress are under investigation as drivers of the recent uptick in EOCRC in the United States (US) and other Westernized countries. Obesity in early adulthood is strongly associated with increased risk of EOCRC; in the US, obesity affects 42% of adults. In addition, obesity is associated with metabolic, hormonal, and immune perturbations that can promote gene mutations that drive EOCRC tumorigenesis. Chronic stress can negatively impact several different systems of the human body including the sympathetic nervous system (SNS)-related catecholamines, epinephrine and norepinephrine, and hypothalamic-pituitary-adrenal (HPA)-axis related hormones including adrenocorticotropic hormone and the glucocorticoid, cortisol. Due to the broad impact that exposure to chronic stress has in the human body, chronic stress has been linked to several diseases, including cancer. The gut and the brain are connected through a bidirectional system coined the gut-microbiota-brain axis (GMBA). Chronic stress can disrupt the SNS, HPA-axis and immune system, leading to a shift in gut microbial ecology and metabolic function that tips the balance to a more pro-inflammatory colonic state conducive to the formation of EOCRC. This study will examine if mitigating chronic stress and weight loss can modify EOCRC risk in young adults at risk of EOCRC. Accumulating evidence suggests that time-restricted eating (TRE), a type of intermittent fasting, produces a ~300-500 kcal/d energy deficit by limiting an individual's daily eating window to 4-8 hours each day. Mindfulness meditation is the practice of cultivating a moment-to-moment awareness of internal and external experience in an accepting and open manner. In 1990, Kabat-Zinn developed Mindfulness Based Stress Reduction (MBSR): an intervention with a goal of reducing stress, pain, and suffering. MBSR is associated with lower perceived stress and decreased circulating cortisol concentrations. Existing evidence suggests that MBSR also yields EOCRC preventive effects specific to body weight reduction, increase of insulin sensitivity and reduction of inflammation. We propose to conduct an 8-week 4-arm randomized-controlled study of 1. TRE alone; 2. MBSR alone; 3. TRE + MBSR; and 4. Control among 40 young adults with obesity (BMI ≥ 30 kg/m2) and moderate to severe perceived stress (Perceived Stress Score ≥14) to evaluate the feasibility of the interventions and preliminary effect on EOCRC-related markers. Data generated from this preliminary trial would serve in developing a fully powered efficacy trial testing TRE+MBSR for EOCRC prevention among young adults in the Chicagoland area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRE alone | Experimental | Participants will be instructed to eat ad libitum from noon - 8:00pm daily and fast from 8:00pm - noon (16-h fast) for 8 weeks. During the 8-h eating window, there will be no restrictions on types or quantities of foods consumed. Participants will meet with a registered dietitian (RD) for 30 minutes at the start of the intervention to review instructions and goals and weekly thereafter. Adherence to the TRE intervention will be assessed as the number of adherent days per week. |
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| MBSR alone | Experimental | Participants in this study will be granted access to a remote mindfulness-based stress reductions (MBSR) protocol. Participants will have access to the MBSR course, consisting of 30 audio lessons, each ranging from 9 to 14 minutes long. During the study, participants will be asked to complete four lessons per week during weeks 1-7 and two lessons during week 8. |
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| TRE + MBSR | Experimental | This group will follow a combined protocol of the TRE and MBSR interventions as described above. |
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| Control | No Intervention | The control group will not receive any of the interventions previously described. To maintain a relationship with each participant in the control group, we will contact them once a week via text message to engage them to finalize the intervention period. At the end of the intervention period and after all data is collected, the RD will meet with the participant for 30 minutes and will educate them regarding the TRE protocol and provide access to the MBSR web-based program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRE | Behavioral | daily ad libitum food intake, 8-h 12pm - 8pm, 8 wks active weight loss phase; |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the study | the number of people interested in the study, those who pass phone and in-person screenings, and those who decline enrollment and their reasons. Once enrolled, we will closely monitor attendance, data completeness, session attendance, asynchronous intervention usage, and loss to follow-up/withdrawal. To monitor participant progress, we will update the CONSORT participant flow diagram every week. Participants who withdraw voluntarily will be asked for their reasons. | Baseline; through study completion, an average of 9 weeks |
| Acceptability of the study | Participants will complete the acceptability of intervention measure (scores range from 4-20 points with higher scores reflecting higher acceptability). | Week 4 of the intervention; through study completion, an average of 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hair cortisol | Objective stress markers will be measured via hair cortisol | Baseline; through study completion, an average of 9 weeks |
| Serum adrenocorticotropic hormone (ACTH) | Objective stress markers will be measured via serum ACTH. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manoela Lima Oliveira, MS, RD, LDN | PhD Candidate | Principal Investigator |
| Lisa M Tussing-Humphreys, PHD, RD | Associate Professor, Kinesiology and Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Health Sciences Building - University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35443109 | Background | Sinicrope 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. | |
| 22952311 | Background | Doubeni 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. |
| Label | URL |
|---|---|
| If you are interested in this research, please answer some eligibility questions in the survey linked here. | View source |
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| MBSR | Behavioral | Completed 30 sessions of a Mindfulness-Based Stress Reduction (MBSR) interventions for 8 weeks |
|
| Baseline; through study completion, an average of 9 weeks |
| Serum cortisol | Objective stress markers will be measured via serum cortisol. | Baseline; through study completion, an average of 9 weeks |
| Serum norepinephrine | Objective stress markers will be measured via serum norepinephrine | Baseline; through study completion, an average of 9 weeks |
| Perceived Stress Scale. | The Perceived Stress Scale queries participants' perceptions of feeling stress during the last month. Responses were on a 5-point scale from "never" to "very often." Scores will be summed to indicate current stress levels, with higher scores suggesting greater perceived stress (≥ 14 indicates moderate to high perceived stress). | Screening; through study completion, an average of 9 weeks |
| Body fat mass | Body fat mass will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan. | Baseline; through study completion, an average of 9 weeks |
| Body lean mass | Body lean mass will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan. | Baseline; through study completion, an average of 9 weeks |
| Body bone density | Body bone density will be measured via whole body dual energy x-ray absorptiometry (DEXA) scan. | Baseline; through study completion, an average of 9 weeks |
| Triglycerides | Will be measured from plasma by a commercial lab. | Baseline; through study completion, an average of 9 weeks |
| High sensitivity C-reactive protein. | Will be measured from plasma by a commercial lab. | Baseline; through study completion, an average of 9 weeks |
| homeostasis model assessment-insulin resistance (HOMA-IR) | calculated from fasting glucose and insulin using a standard formula. | Baseline; through study completion, an average of 9 weeks |
| Microbial Deoxyribonucleic acid (DNA) isolation: 16S on V4 region | performed on stool using Microbial DNA isolation | Baseline; through study completion, an average of 9 weeks |
| 40924443 | Derived | Lima 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015179 | Colorectal Neoplasms |
| D003141 | Communicable Diseases |
| D000093763 | Intermittent Fasting |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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