Medically Tailored Meals to Reduce Ultra-processed Food Intake in Colorectal Cancer Survivors (MTM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer (Diagnosis)
• Intervention / Treatment: Behavioral: MTM: Medically tailored meals; Behavioral: MTM plus Fresh Produce; Behavioral: Control group

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengxi Du, RD, PhD, MPH; Phone Number: 617-726-5405; Email: mdu1@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Mengxi Du, RD, PhD, MPH; Phone Number: 617-726-5405; Email: mdu1@mgh.harvard.edu
      • Principal Investigator: Mengxi Du, RD, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;
  • 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medically Tailored Meals (MTM); 3 prepared meals per day (i.e., breakfast, lunch, and dinner) for a total of 126 meals.	Behavioral: MTM: Medically tailored meals; 3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
Experimental: Medically Tailored Melas (MTM) plus Fresh Produce; 2 prepared meals per day (84 meals total), plus weekly fresh produce and recipes to help prepare a third meal each day.	Behavioral: MTM plus Fresh Produce; 2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
Active Comparator: Control group; weekly meal planning materials and recipes only; no food will be provided.	Behavioral: Control group; weekly recipes and meal-planning materials only; no food will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	From enrollment to the final visit at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MTM Impact on Diet	The extent to which the MTM-based intervention improves dietary intake and food insecurity across study arms	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	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.	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.	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.	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.	From enrollment to the final visit at 8 weeks
Longitudinal Biomarker Changes	Changes in clinical biomarkers using EHR data.	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.	From enrollment to the end of study, assessed at year 3 follow-up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mengxi Du, RD, PhD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): August 10, 2028
• Study Completion (Estimated): October 10, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: colorectal cancer; survival; health outcomes; medically tailored meals; ultra processed foods
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Disease; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups; myotubularin
• Other Study ID Numbers: 26-210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the MGB Innovation at PHSINNOVATIONSUPPORT@partners.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No