Nutritional Language Model (NLM)

May 13, 2025 updated by: University of Minnesota

Comparative Analysis Between Artificial Intelligence vs. Human Generated Nutrition Messages for Colorectal Cancer Survivors

Colorectal cancer survivors often face unique nutritional challenges and require support in their recovery and long0term health. While human experts have traditionally provided that support, there has been an increase in the use of Large Language Models (LLM) in medicine and in nutrition. The LLM offers a potential supplementary resource for generating personalized nutritional advice, specifically in personalized messaging. However, the efficacy and reliability of these AI-generated messages in comparison to human expert advice remain underexplored specific to this population.

This study aims to compare the nutrition-related content generated by popular LLMs-ChatGPT, Claude, Gemini, and Co-Pilot-against messages crafted by human experts. By evaluating the generated content in terms of readability, thematic relevance, medical relevance, perceived effectiveness, and implementation of participants' clinical practice, this research will provide insights into the strengths and limitations of using AI for nutritional guidance in colorectal cancer care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Austin, Minnesota, United States, 55912
        • The Hormel Institute - University of Minnesota, Medical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18+ years of age
  • Currently practicing Registered Dietitian Nutritionist with at least five years of experience working with oncology patients and survivors in their practice.
  • Must have access to computer and internet access.

Exclusion Criteria:

  • Non-English speakers, as the study materials and assessments are in English.
  • Experts with conflicts of interest related to any of the LLMs that are being evaluated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietician
Other: Nutritional Messaging
Dieticians will evaluate nutritional messages created by LLM and Human Experts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome Measure Title: Readability of Nutrition Messages
Time Frame: 8 to 12 months

Description: The readability of AI-generated and human expert-generated nutrition messages will be measured using the Flesch-Kincaid Grade Level tool.

Unit of Measure: Grade level score (numerical score indicating reading difficulty level).

Measurement Tool: Flesch-Kincaid Grade Level formula. Scale values: The values vary from 0 to 18, where 18 represents the most difficult text.
8 to 12 months
Outcome Measure Title: Thematic Relevance of Nutrition Messages
Time Frame: 8 to 12 months

Description: Thematic relevance of nutrition messages will be assessed by experts in nutrition using a thematic coding framework specifically designed for this study.

Unit of Measure: Percentage (%) of messages that align with pre-determined thematic codes relevant to colorectal cancer survivorship.

Measurement Tool: Thematic coding framework created by the research team. Scale values: The themes are capability (C), opportunity (O), and motivation (M) as three key factors capable of changing behavior (B).
8 to 12 months
Outcome Measure Title: Medical Relevance to Colorectal Cancer Survivors
Time Frame: 8-12 months

Description: Medical relevance will be rated by specialists using a 0-5 relevance rating scale.

Unit of Measure: Mean relevance score (0-5). Measurement Tool: Dietitians/Participants review using a relevance rating scale.

Scale value: 1-5 (1- least, 5- most)
8-12 months
Outcome Measure Title: Perceived Effectiveness of Nutrition Messages
Time Frame: 8-12 months

Description: Perceived effectiveness will be measured using a mean relevance score (1-5) administered to dietitians and participants.

Unit of Measure: Mean relevance score (1-5). Measurement Tool: Dietitians/Participants survey. Scale value: 1-5 (1- least, 5- most)
8-12 months
Outcome Measure Title: Potential for Implementation in Clinical Practice
Time Frame: 8-12 months

Description: Feasibility for clinical implementation will be rated by dietitians using a 1-5 feasibility scale.

Unit of Measure: Mean feasibility score. Measurement Tool: Dietitians/Participants survey. Scale value: 1-5 (1- least, 5- most)
8-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Annie Lin, RD, PhD, Hormel Institute
  • Study Chair: Glen Morris, PhD, Hormel Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

February 6, 2025

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00023189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan on sharing the list of participation. This is due to the expected low enrollment amount of 6 participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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