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

NCT06022887 | Completed DMC

• 1 other identifier: STUDY2023-0498
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

obesity; Time Restricted Feeding; microbiome; chronic stress

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (12)

• Hair cortisol

  Baseline; through study completion, an average of 9 weeks

• Serum adrenocorticotropic hormone (ACTH)

  Baseline; through study completion, an average of 9 weeks

• Serum cortisol

  Baseline; through study completion, an average of 9 weeks

• Serum norepinephrine

  Baseline; through study completion, an average of 9 weeks

• Perceived Stress Scale.

  Screening; through study completion, an average of 9 weeks

Study Arms (4)

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.

Behavioral: TRE

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.

Behavioral: MBSR

TRE + MBSR

EXPERIMENTAL

This group will follow a combined protocol of the TRE and MBSR interventions as described above.

Behavioral: TRE; Behavioral: MBSR

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.

Interventions

TRE BEHAVIORAL

daily ad libitum food intake, 8-h 12pm - 8pm, 8 wks active weight loss phase;

TRE + MBSR; TRE alone

MBSR BEHAVIORAL

Completed 30 sessions of a Mindfulness-Based Stress Reduction (MBSR) interventions for 8 weeks

MBSR alone; TRE + MBSR

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Lisa Tussing-Humphreys: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Applied Health Sciences Building - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 35443109 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.

  PMID: 22952311 BACKGROUND

Related Links

• If you are interested in this research, please answer some eligibility questions in the survey linked here.

MeSH Terms

Conditions

Obesity; Colorectal Neoplasms; Communicable Diseases; Intermittent Fasting; Stress, Psychological

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Infections; Disease Attributes; Pathologic Processes; Fasting; Feeding Behavior; Behavior; Behavioral Symptoms

Study Officials

• Manoela Lima Oliveira, MS, RD, LDN

  PhD Candidate

  PRINCIPAL INVESTIGATOR

• Lisa M Tussing-Humphreys, PHD, RD

  Associate Professor, Kinesiology and Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 5, 2023
• Study Start: October 18, 2023
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)