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

2026年7月8日 更新者:Mengxi Du、Massachusetts General Hospital

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
        • 接触:
        • 首席研究员:
          • Mengxi Du, RD, PhD, MPH

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Medically Tailored Meals (MTM)
3 prepared meals per day (i.e., breakfast, lunch, and dinner) for a total of 126 meals.
3 fully prepared, home-delivered, medically tailored meals per day delivered weekly for 6 weeks.
实验性的: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.
2 fully prepared, home-delivered, medically tailored meals per day, plus weekly deliveries of fresh produce and accompanying recipes, for 6 weeks.
有源比较器:Control group
weekly meal planning materials and recipes only; no food will be provided.
weekly recipes and meal-planning materials only; no food will be provided.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Evaluation of feasibility of consuming medically tailored meals through study participation
大体时间: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

From enrollment to the end of study, assessed at year 3 follow-up
Evaluation of feasibility of consuming medically tailored meals through retention
大体时间: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

From enrollment to the end of study, assessed at year 3 follow-up
Evaluation of feasibility of consuming medically tailored meals through compliance
大体时间: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

From enrollment to the final visit at 8 weeks

次要结果测量

结果测量
措施说明
大体时间
MTM Impact on Diet
大体时间:From enrollment to the end of study, assessed at year 3 follow-up
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
大体时间:From enrollment to the end of study, assessed at year 3 follow-up
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
大体时间:From enrollment to the final visit at 8 weeks
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
大体时间:From enrollment to the final visit at 8 weeks
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
大体时间:From enrollment to the final visit at 8 weeks
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
大体时间:From enrollment to the final visit at 8 weeks
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
大体时间:From enrollment to the end of study, assessed at year 3 follow-up
Changes in clinical biomarkers using EHR data.
From enrollment to the end of study, assessed at year 3 follow-up
Longitudinal Disease Progression Changes
大体时间:From enrollment to the end of study, assessed at year 3 follow-up
Changes in disease progression outcomes using EHR data.
From enrollment to the end of study, assessed at year 3 follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mengxi Du, RD, PhD, MPH、Massachusetts General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月10日

初级完成 (估计的)

2028年8月10日

研究完成 (估计的)

2028年10月10日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月8日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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 共享时间框架

Data can be shared no earlier than 1 year following the date of publication

IPD 共享访问标准

Contact the MGB Innovation at PHSINNOVATIONSUPPORT@partners.org

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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