ObesityMBSR&TRENCT06022887
Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer
A study testing TRE and MBSR in people with Obesity and Colorectal Cancer, run by Lisa Tussing-Humphreys at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Colorectal Cancer, Microbial Colonization
- What is being tested?
- TRE and MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 24 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-39 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- Night shift workers (shift passes midnight).
- Present a history of eating disorder.
- Currently taking weight loss medication.
- Illegal drug use in the past month (not marijuana).
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Health Sciences Building - University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Feasibility and Acceptability of a Remote Time-Restricted Eating and Mindfulness-Based Stress Reduction Intervention to Reduce Risk Factors Associated With Early-Onset Colorectal Cancer Development Among Young Adults
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Obesity, Colorectal Cancer, Microbial Colonization, Time Restricted Feeding, Stress, Psychological
- Being tested
- TRE, MBSR
- Keywords
- obesity; Time Restricted Feeding; microbiome; chronic stress
- Medical subject headings
- Obesity, Colorectal Neoplasms, Communicable Diseases, Intermittent Fasting, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREBehavioural
daily ad libitum food intake, 8-h 12pm - 8pm, 8 wks active weight loss phase;
MBSRBehavioural
Completed 30 sessions of a Mindfulness-Based Stress Reduction (MBSR) interventions for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: MBSR |
| TRE + MBSR | Experimental | This group will follow a combined protocol of the TRE and MBSR interventions as described above. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Week 4 of the intervention; through study completion, an average of 9 weeks
Secondary outcomes (12)
Hair cortisol
Objective stress markers will be measured via hair cortisol
Measured: Baseline; through study completion, an average of 9 weeks
Serum adrenocorticotropic hormone (ACTH)
Objective stress markers will be measured via serum ACTH.
Measured: Baseline; through study completion, an average of 9 weeks
Serum cortisol
Objective stress markers will be measured via serum cortisol.
Measured: Baseline; through study completion, an average of 9 weeks
Serum norepinephrine
Objective stress markers will be measured via serum norepinephrine
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; through study completion, an average of 9 weeks
Triglycerides
Will be measured from plasma by a commercial lab.
Measured: Baseline; through study completion, an average of 9 weeks
High sensitivity C-reactive protein.
Will be measured from plasma by a commercial lab.
Measured: 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.
Measured: 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
Measured: Baseline; through study completion, an average of 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start18 Oct 2023
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Tussing-Humphreys
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Sponsor-investigator, Lisa Tussing-Humphreys, University of Illinois Chicago
- Investigators
- Manoela Lima Oliveira, MS, RD, LDN, Principal investigator, PhD CandidateLisa M Tussing-Humphreys, PHD, RD, Principal investigator, Associate Professor, Kinesiology and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022887
- Sponsor's protocol ID
- STUDY2023-0498
- Acronym
- MBSR&TRE
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35443109Doubeni 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.
PubMed 22952311Lima 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.
PubMed 40924443
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Remote Time-Restricted Eating and Mindfulness-Based Stress Reduction Intervention to Reduce Risk Factors Associated With Early-Onset Colorectal Cancer Development Among Young Adults
- ClinicalTrials.gov ID
- NCT06022887
- Acronym / sponsor ID
- MBSR&TRE / STUDY2023-0498
- Conditions
- Obesity, Colorectal Cancer, Microbial Colonization, Time Restricted Feeding, Stress, Psychological
- Keywords
- obesity; Time Restricted Feeding; microbiome; chronic stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Lisa Tussing-HumphreysUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TRE alone | Experimental | Behavioral: TREParticipants 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. |
| MBSR alone | Experimental | Behavioral: MBSRParticipants 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. |
| TRE + MBSR | Experimental | Behavioral: TRE, Behavioral: MBSRThis group will follow a combined protocol of the TRE and MBSR interventions as described above. |
| 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-39 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREdaily ad libitum food intake, 8-h 12pm - 8pm, 8 wks active weight loss phase; | Behavioural | TRE + MBSR, TRE alone |
| MBSRCompleted 30 sessions of a Mindfulness-Based Stress Reduction (MBSR) interventions for 8 weeks | Behavioural | MBSR alone, TRE + MBSR |
Primary outcome
Feasibility of the study
Time frame: Baseline; through study completion, an average of 9 weeks
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.
Acceptability of the study
Time frame: Week 4 of the intervention; through study completion, an average of 9 weeks
Participants will complete the acceptability of intervention measure (scores range from 4-20 points with higher scores reflecting higher acceptability).
12 secondary outcomes
Hair cortisol
Time frame: Baseline; through study completion, an average of 9 weeks
Serum adrenocorticotropic hormone (ACTH)
Time frame: Baseline; through study completion, an average of 9 weeks
Serum cortisol
Time frame: Baseline; through study completion, an average of 9 weeks
Serum norepinephrine
Time frame: Baseline; through study completion, an average of 9 weeks
Perceived Stress Scale.
Time frame: Screening; through study completion, an average of 9 weeks
Body fat mass
Time frame: Baseline; through study completion, an average of 9 weeks
Body lean mass
Time frame: Baseline; through study completion, an average of 9 weeks
Body bone density
Time frame: Baseline; through study completion, an average of 9 weeks
Triglycerides
Time frame: Baseline; through study completion, an average of 9 weeks
High sensitivity C-reactive protein.
Time frame: Baseline; through study completion, an average of 9 weeks
homeostasis model assessment-insulin resistance (HOMA-IR)
Time frame: Baseline; through study completion, an average of 9 weeks
Microbial Deoxyribonucleic acid (DNA) isolation: 16S on V4 region
Time frame: Baseline; through study completion, an average of 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 35443109Sinicrope 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.
- Background: PubMed 22952311Doubeni 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.
- Derived from this study: PubMed 40924443Lima 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.
- If you are interested in this research, please answer some eligibility questions in the survey linked here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoela Lima Oliveira, MS, RD, LDN principal investigator
PhD Candidate
Lisa M Tussing-Humphreys, PHD, RD principal investigator
Associate Professor, Kinesiology and Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRE and MBSR in people with Obesity and Colorectal Cancer, run by Lisa Tussing-Humphreys at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study (time frame: Baseline; through study completion, an average of 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06022887, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.