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

Official title

A Pilot Medically Tailored Meal-Based Intervention to Reduce Ultra-processed Food Intake Among Patients With Stages I-III Colorectal Cancer

Overview

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.

Interventions

• Behavioral MTM: Medically tailored meals
  3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
• 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.
• Behavioral Control group
  weekly recipes and meal-planning materials only; no food will be provided.

Primary outcome measures

• 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]
• 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]
• Evaluation of feasibility of consuming medically tailored meals through compliance [Time frame: From enrollment to the final visit at 8 weeks]

Secondary outcome measures (8)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07701707 · 26-210

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗