NCT07557979

Brief Summary

Many non-communicable diseases are diet-related and have a significant impact on public health. It is stated that global dietary shifts are needed to change disease patterns, highlighting the importance of nutrition in addressing public health issues, such as obesity. The field of nutrition has been dependent on clinical and observational studies; however, the emergence of Artificial Intelligence (AI) is transforming these approaches. ChatGPT may be used to provide dietary recommendations due to its high speed, extensive access to a variety of meal data, and low complexity. However, initial evaluations have shown that ChatGPT may be inaccurate in terms of safety and reliability, and traditional nutrition approaches are highly reliant on experts' knowledge and the validity of nutritional guidelines. It has been suggested that AI in nutrition may be beneficial; however, further investigations are needed. Our proposal aims to fill the represented critical evidence gaps. The study aims to compare the health effects of an AI-driven model with those of human professional guidelines for the treatment of obesity. Furthermore, we seek better strategies to utilize AI, if appropriate, for weight loss and other health benefits.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

An AI-driven modelHuman professional guidelinesTreatment of obesity

Outcome Measures

Primary Outcomes (1)

  • Weight change

    8 weeks

Study Arms (3)

AI-only group using ChatGPT Premium

EXPERIMENTAL

A human assisted AI (ChatGPT Premium), in which dietary plans are developed and clinical judgment will be made.

Other: AI-assisted dietitian group (combination)Other: A dietitian-led group (human)Other: AI-only group using ChatGPT Premium

A dietitian-led group (human)

EXPERIMENTAL

A dietitian-led group (human), in which dietary plans are developed by a licensed dietitian using standard professional resources and clinical judgment, without the use of generative AI tools.

Other: AI-assisted dietitian group (combination)Other: A dietitian-led group (human)Other: AI-only group using ChatGPT Premium

AI-assisted dietitian group (combination)

ACTIVE COMPARATOR

An AI-assisted dietitian group (combination), in which the same dietitian is permitted to use ChatGPT Premium as a supportive tool during the consultation

Other: AI-assisted dietitian group (combination)Other: A dietitian-led group (human)Other: AI-only group using ChatGPT Premium

Interventions

• An AI-assisted dietitian group (combination), in which the same dietitian is permitted to use ChatGPT Premium as a supportive tool during the consultation.

A dietitian-led group (human)AI-assisted dietitian group (combination)AI-only group using ChatGPT Premium

A dietitian-led group (human), in which dietary plans are developed by a licensed dietitian using standard professional resources and clinical judgment, without the use of generative AI tools.

A dietitian-led group (human)AI-assisted dietitian group (combination)AI-only group using ChatGPT Premium

Arm Description: A human assisted AI (ChatGPT Premium), in which dietary plans are developed and clinical judgment will be made.

A dietitian-led group (human)AI-assisted dietitian group (combination)AI-only group using ChatGPT Premium

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with age 18 to 60 years, BMI\>30, living in Lubbock-TX and willing to participate in the study.

You may not qualify if:

  • Pregnant or breastfeeding women or recent (within the past 6 months) diagnosis of a severe/acute medical condition (e.g., acute pancreatitis, cancer), or any other chronic diseases except obesity (e.g., diabetes, chronic kidney diseases, psychiatric conditions) or taking any anti-obesity medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Surya Raj Niraula, PhD, Postdoc

CONTACT

Shannon Galyean, PhD, RDN, LD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 30, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share