Colorectal Cancer (Diagnosis)MTMNCT07701707
Medically Tailored Meals to Reduce Ultra-processed Food Intake in Colorectal Cancer Survivors
A study testing MTM: Medically tailored meals and MTM plus Fresh Produce in people with Colorectal Cancer (Diagnosis), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is a three-arm, parallel-group randomized clinical trial that examines the feasibility and initial impact of consuming medically tailored meals to reduce intake of ultra-processed food and improve health and survival outcomes among 60 patients with stage I-III colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (Diagnosis)
- What is being tested?
- MTM: Medically tailored meals and MTM plus Fresh Produce
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2026to 10 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy, and radiotherapy) at least 2 months ago.
- Age ≥18 years.
- ECOG = 0 or 1
- Participants must have a high intake of UPFs, defined as meeting at least three of the following criteria, each consumed on more than or equal to 3 days per week:
- Ready-to-eat or ready-to-heat dishes, such as packaged frozen meals, prepared entrées, quick dishes, or microwaveable packaged foods;
- Sugar- or artificially sweetened beverages (e.g., soda, diet coke, sweetened teas, bubble tea, flavored instant coffee mixes), alcoholic beverages, or other commercially prepared sweetened drinks;
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- Packaged snack foods, such as chips, cookies, ice cream, desserts, or other commercially prepared snack items;
- Frequent fast-food consumption, including meals or beverages purchased from fast-food or quick-service restaurants, such as McDonald's, Wendy's, KFC, Burger King, Five Guys, Chick-fil-A, Dairy Queen, etc.
- Home-cooked meals that rely primarily on pre-prepared ingredients, such as deli meats, canned fish, canned fruits and vegetables, frozen foods or ingredients, or similar products used more often than fresh produce, raw meat/seafood, or raw fruits and vegetables.
- Subjects must be able and willing to follow study procedures and instructions.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who are receiving any other investigational agents or lifestyle/dietary interventions.
- Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
- Any prior diagnosis of invasive (i.e., excluding intramucosal cancer) gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (except non-melanoma skin) in which there has been any active treatment within the last three years.
- Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.
- Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
- Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.
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- Participants who are pregnant Participants who may become pregnant or partners of those who may become pregnant while on study will receive contraception counseling. Participants or partners of those who become pregnant while participating in the study should immediately inform their doctor.
- Participants who are unwilling to make dietary changes.
- Individuals who do not have access to or are not able to participate in remote nutrition counseling and assessment sessions via Zoom or phone calls.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mengxi Du, RD, PhD, MPH, 617-726-5405, mdu1@mgh.harvard.edu
Mengxi Du, RD, PhD, MPH
About this study
Official title: A Pilot Medically Tailored Meal-Based Intervention to Reduce Ultra-processed Food Intake Among Patients With Stages I-III Colorectal Cancer
This research study is a three-arm, parallel-group randomized clinical trial that examines the feasibility and initial impact of consuming medically tailored meals to reduce intake of ultra-processed food and improve health and survival outcomes among 60 patients with stage I-III colorectal cancer.
Read the detailed description
This research study is exploring whether medically tailored meals can help survivors with stage I-III colorectal cancer reduce their intake of ultra-processed foods and improve their health. Ultra-processed foods, such as packaged snacks, fast food, and sugary drinks, make up a large portion of many Americans' diets and have been linked to a higher risk of colorectal cancer and poorer survival. While experts recommend limiting these foods, many patients face challenges like limited time, cooking skills, or access to healthy options, making dietary changes difficult.
Medically tailored meals, designed by dietitians to meet specific health needs, may offer a practical solution by making healthy eating easier and more accessible. This study will evaluate whether these meals, with or without fresh produce, can improve diet quality, support healthier gut bacteria, and reduce inflammation. Researchers will measure changes in gut health and blood markers before and after the program to better understand how diet can influence recovery and long-term outcomes for colorectal cancer survivors.
This research study will last about 3 years. It includes a 2-week preparation period, a 6-week intervention with a medically tailored meals (MTM) program, 2 clinic visits (one prior to starting and one following the 6-week intervention period), 2 nutrition counseling visits with a registered dietitian (also conducted before and after the intervention), and follow-up contacts (4 weeks after the final visit and then every year for 3 years).
Because it is unknown which meal plan is best, participants will be randomized to one of these 3 meal plan groups:
- MTM: participants will receive 3 fully prepared, home-delivered, medically tailored meals per day for 6 weeks.
- MTM plus Fresh Produce: participants will receive 2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
- Control group: participants will receive weekly recipes and meal-planning materials only; no food will be provided.
- Conditions
- Colorectal Cancer (Diagnosis)
- Being tested
- MTM: Medically tailored meals, MTM plus Fresh Produce, Control group
- Keywords
- colorectal cancer, medically tailored meals, ultra processed foods, survival, health outcomes
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTM: Medically tailored mealsBehavioural
3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
MTM plus Fresh ProduceBehavioural
2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
Control groupBehavioural
weekly recipes and meal-planning materials only; no food will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Medically Tailored Meals (MTM) | Experimental | 3 prepared meals per day (i.e., breakfast, lunch, and dinner) for a total of 126 meals. Receives: Behavioral: MTM: Medically tailored meals |
| Medically Tailored Melas (MTM) plus Fresh Produce | Experimental | 2 prepared meals per day (84 meals total), plus weekly fresh produce and recipes to help prepare a third meal each day. Receives: Behavioral: MTM plus Fresh Produce |
| Control group | Active comparator | weekly meal planning materials and recipes only; no food will be provided. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of feasibility of consuming medically tailored meals through study participation
Feasibility will be assessed by the following metrics:
- percentage of eligible patients who enroll
Measured: From enrollment to the end of study, assessed at year 3 follow-up
Evaluation of feasibility of consuming medically tailored meals through retention
Feasibility will be assessed by the following metrics:
- percentage of enrolled participants who complete study visits and outcome assessments
Measured: From enrollment to the end of study, assessed at year 3 follow-up
Evaluation of feasibility of consuming medically tailored meals through compliance
Feasibility will be assessed by the following metrics:
- proportion of participants who adhere to assigned interventions, defined as consumption of provided meals and/or produce (for intervention arms), completion of at least two dietary assessments, and provision of blood, tumor tissue, and fecal samples at baseline and end of intervention
Measured: From enrollment to the final visit at 8 weeks
Secondary outcomes (8)
MTM Impact on Diet
The extent to which the MTM-based intervention improves dietary intake and food insecurity across study arms
Measured: From enrollment to the end of study, assessed at year 3 follow-up
MTM Impact on Patient Outcomes
The extent to which the MTM-based intervention improves quality of life and patient-reported outcomes across study arms
Measured: From enrollment to the end of study, assessed at year 3 follow-up
Relative Composition of Gut Microbiome Features
Comparing change in gut microbiome features (species - to strain level specificity; metabolic pathways; enzymes) using deep meta'omic profiling in pre- and post- treatment samples.
Measured: From enrollment to the final visit at 8 weeks
Relative Composition of Gut Metabolites
Comparing change in gut metabolites using deep meta'omic profiling in pre- and post- treatment samples.
Measured: From enrollment to the final visit at 8 weeks
Change in Stool Metabolomics
Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.
Measured: From enrollment to the final visit at 8 weeks
Change in Plasma Metabolomics
Comparing change in plasma metabolomics, using non-targeted global metabolomics analysis on blood samples to examine intensity changes in the blood metabolite profile.
Measured: From enrollment to the final visit at 8 weeks
Longitudinal Biomarker Changes
Changes in clinical biomarkers using EHR data.
Measured: From enrollment to the end of study, assessed at year 3 follow-up
Longitudinal Disease Progression Changes
Changes in disease progression outcomes using EHR data.
Measured: From enrollment to the end of study, assessed at year 3 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start10 Aug 2026 (estimated)
- Primary completion10 Aug 2028 (estimated)
- Study completion10 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mengxi Du, Massachusetts General Hospital
- Investigators
- Mengxi Du, RD, PhD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701707
- Sponsor's protocol ID
- 26-210
- Acronym
- MTM
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Mengxi Du, RD, PhD, MPH. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Medically Tailored Meal-Based Intervention to Reduce Ultra-processed Food Intake Among Patients With Stages I-III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07701707
- Acronym / sponsor ID
- MTM / 26-210
- Conditions
- Colorectal Cancer (Diagnosis)
- Keywords
- colorectal cancer, medically tailored meals, ultra processed foods, survival, health outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 10 Aug 2028 (estimated)
- Study completion
- 10 Oct 2028 (estimated)
- First posted
- 14 Jul 2026 (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.
This research study is a three-arm, parallel-group randomized clinical trial that examines the feasibility and initial impact of consuming medically tailored meals to reduce intake of ultra-processed food and improve health and survival outcomes among 60 patients with stage I-III colorectal cancer.
Detailed description
This research study is exploring whether medically tailored meals can help survivors with stage I-III colorectal cancer reduce their intake of ultra-processed foods and improve their health. Ultra-processed foods, such as packaged snacks, fast food, and sugary drinks, make up a large portion of many Americans' diets and have been linked to a higher risk of colorectal cancer and poorer survival. While experts recommend limiting these foods, many patients face challenges like limited time, cooking skills, or access to healthy options, making dietary changes difficult.
Medically tailored meals, designed by dietitians to meet specific health needs, may offer a practical solution by making healthy eating easier and more accessible. This study will evaluate whether these meals, with or without fresh produce, can improve diet quality, support healthier gut bacteria, and reduce inflammation. Researchers will measure changes in gut health and blood markers before and after the program to better understand how diet can influence recovery and long-term outcomes for colorectal cancer survivors.
This research study will last about 3 years. It includes a 2-week preparation period, a 6-week intervention with a medically tailored meals (MTM) program, 2 clinic visits (one prior to starting and one following the 6-week intervention period), 2 nutrition counseling visits with a registered dietitian (also conducted before and after the intervention), and follow-up contacts (4 weeks after the final visit and then every year for 3 years).
Because it is unknown which meal plan is best, participants will be randomized to one of these 3 meal plan groups:
- MTM: participants will receive 3 fully prepared, home-delivered, medically tailored meals per day for 6 weeks.
- MTM plus Fresh Produce: participants will receive 2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
- Control group: participants will receive weekly recipes and meal-planning materials only; no food will be provided.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medically Tailored Meals (MTM) | Experimental | Behavioral: MTM: Medically tailored meals3 prepared meals per day (i.e., breakfast, lunch, and dinner) for a total of 126 meals. |
| Medically Tailored Melas (MTM) plus Fresh Produce | Experimental | Behavioral: MTM plus Fresh Produce2 prepared meals per day (84 meals total), plus weekly fresh produce and recipes to help prepare a third meal each day. |
| Control group | Active comparator | Behavioral: Control groupweekly meal planning materials and recipes only; no food will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy, and radiotherapy) at least 2 months ago.
- Age ≥18 years.
- ECOG = 0 or 1
- Participants must have a high intake of UPFs, defined as meeting at least three of the following criteria, each consumed on more than or equal to 3 days per week:
- Subjects must be able and willing to follow study procedures and instructions.
Key exclusion criteria (9 listed)
- Participants who are receiving any other investigational agents or lifestyle/dietary interventions.
- Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
- Any prior diagnosis of invasive (i.e., excluding intramucosal cancer) gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (except non-melanoma skin) in which there has been any active treatment within the last three years.
- Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.
- Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
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 |
|---|---|---|
| MTM: Medically tailored meals3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks. | Behavioural | Medically Tailored Meals (MTM) |
| MTM plus Fresh Produce2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks. | Behavioural | Medically Tailored Melas (MTM) plus Fresh Produce |
| Control groupweekly recipes and meal-planning materials only; no food will be provided. | Behavioural | Control group |
Primary outcome
Evaluation of feasibility of consuming medically tailored meals through study participation
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
Feasibility will be assessed by the following metrics: • percentage of eligible patients who enroll
Evaluation of feasibility of consuming medically tailored meals through retention
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
Feasibility will be assessed by the following metrics: • percentage of enrolled participants who complete study visits and outcome assessments
Evaluation of feasibility of consuming medically tailored meals through compliance
Time frame: From enrollment to the final visit at 8 weeks
Feasibility will be assessed by the following metrics: • proportion of participants who adhere to assigned interventions, defined as consumption of provided meals and/or produce (for intervention arms), completion of at least two dietary assessments, and provision of blood, tumor tissue, and fecal samples at baseline and end of intervention
8 secondary outcomes
MTM Impact on Diet
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
MTM Impact on Patient Outcomes
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
Relative Composition of Gut Microbiome Features
Time frame: From enrollment to the final visit at 8 weeks
Relative Composition of Gut Metabolites
Time frame: From enrollment to the final visit at 8 weeks
Change in Stool Metabolomics
Time frame: From enrollment to the final visit at 8 weeks
Change in Plasma Metabolomics
Time frame: From enrollment to the final visit at 8 weeks
Longitudinal Biomarker Changes
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
Longitudinal Disease Progression Changes
Time frame: From enrollment to the end of study, assessed at year 3 follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Mengxi Du, RD, PhD, MPH. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Mengxi Du, RD, PhD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTM: Medically tailored meals and MTM plus Fresh Produce in people with Colorectal Cancer (Diagnosis), run by Massachusetts General Hospital 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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengxi Du, RD, PhD, MPH (617-726-5405, mdu1@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of feasibility of consuming medically tailored meals through study participation (time frame: From enrollment to the end of study, assessed at year 3 follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.