Agentic AI Personalized Dietary Management Study (AIDiet)

September 11, 2026 updated by: Su-Yeon Choi, Seoul National University Hospital

Effectiveness of an Agentic AI-Based Personalized Dietary Management Algorithm in Health Screening Participants: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effectiveness of an Agentic AI-based personalized dietary management algorithm among adults undergoing health screening. Participants will be assigned to a control group, a static goal AI intervention group, or an adaptive goal AI intervention group and followed for 12 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a randomized controlled trial designed to evaluate whether an Agentic AI-based personalized dietary management algorithm improves dietary behavior and metabolic health indicators among adults undergoing health screening. Eligible participants will be randomly assigned to one of three groups: standard dietary education and passive dietary recording, AI-generated personalized dietary goals maintained throughout the study period, or adaptive AI-based dietary tracking with dynamic goal adjustment and personalized feedback. Outcomes will be assessed at baseline and after 12 weeks, including dietary evaluation index scores and metabolic health-related clinical indicators.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Suyeon Choi, MD, PhD
  • Phone Number: 02-2112-5639
  • Email: 65390@snuh.org

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 06236
        • Recruiting
        • Seoul National University Hospital Healthcare System Gangnam Center
        • Contact:
          • Su-Yeon Choi, PhD
          • Phone Number: +82-10-2028-5782
          • Email: 65390@snuh.org

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 20 years or older
  • Individuals from the general population who underwent a health examination at the Seoul National University Hospital Healthcare System Gangnam Center
  • Individuals who are capable of independently using a smartphone and operating study-related applications or text messaging functions
  • Individuals without conditions that significantly interfere with standard dietary management, as specified in the exclusion criteria [Section 9.2 Exclusion Criteria]

Exclusion Criteria:

  • Individuals unable to use a smartphone or study-related digital program/application, including those without a smartphone or unable to operate text messaging or application-based functions.
  • End-stage renal disease or patients currently receiving dialysis
  • Active cancer or currently undergoing chemotherapy or radiotherapy
  • Severe heart failure, liver cirrhosis, or hepatic insufficiency accompanied by varices, bleeding, ascites, hepatic encephalopathy, or jaundice
  • Malabsorption disorders such as Crohn's disease or short bowel syndrome
  • Poorly controlled hyperthyroidism or hypothyroidism
  • Diagnosed eating disorders or severe psychiatric disorders
  • Pregnant or breastfeeding women, or women who may become pregnant during study participation.
  • Individuals with recent major weight-related interventions or extreme body weight changes within the past 3 months, including:Bariatric surgery such as gastrectomy or gastric bypass surgery Newly initiated anti-obesity pharmacotherapy (e.g., semaglutide/Wegovy, tirzepatide/Mounjaro)
  • Individuals considered by the investigator to have poor compliance potential or otherwise deemed unsuitable for participation in the clinical study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Participants receive standard dietary education and perform passive dietary recording during the 12-week study period.
Experimental: Static goal AI intervention group
Participants receive AI-generated personalized dietary goals that are maintained during the 12-week intervention period.
Behavioral: Static AI-based personalized dietary goal setting
The AI algorithm generates individualized dietary goals based on baseline information. The generated goals are maintained without dynamic adjustment during the intervention period.
Experimental: Adaptive goal AI intervention group
Participants receive adaptive AI-based dietary tracking, dynamic goal adjustment, and personalized feedback during the 12-week intervention period.
Behavioral: Adaptive AI-based personalized dietary management
The AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Dietary Behavior Score
Time Frame: Baseline and 12 weeks
Dietary behavior will be assessed using a 12-item dietary behavior questionnaire derived from a 19-item dietary assessment questionnaire developed and routinely used at Seoul National University Hospital Gangnam Center. Each item is scored on a 3-point scale (1, 3, or 5 points). Total scores range from 12 to 60, with higher scores indicating healthier dietary behaviors. The change in total dietary behavior score from baseline to 12 weeks will be evaluated. unit:score
Baseline and 12 weeks
Outcome Measure: Change in Client Satisfaction Questionnaire Score (CSQ-8)
Time Frame: from baseline to 12 weeks.
Participant satisfaction with the system will be assessed using the Client Satisfaction Questionnaire-8 (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater satisfaction with the system.unit:score
from baseline to 12 weeks.
Change in System Usability Scale Score (SUS)
Time Frame: from baseline to 12 weeks
System usability will be assessed using the System Usability Scale (SUS). Total scores range from 0 to 100, with higher scores indicating better usability. unit:score
from baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index
Time Frame: Baseline and 12 weeks
Change in body mass index from baseline to 12 weeks. Unit: kg/m²
Baseline and 12 weeks
Change in Waist Circumference
Time Frame: from baseline to 12 weeks
Change in waist circumference from baseline to 12 weeks. Unit : cm
from baseline to 12 weeks
Change in Systolic Blood Pressure
Time Frame: from baseline to 12 weeks.
Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg
from baseline to 12 weeks.
Change in Diastolic Blood Pressure
Time Frame: from baseline to 12 week
Change in diastolic blood pressure from baseline to 12 weeks. Unit:mmHg
from baseline to 12 week
Change in Fasting Glucose
Time Frame: from baseline to 12 weeks.
Change in fasting glucose from baseline to 12 weeks. Unit:mg/dL
from baseline to 12 weeks.
Change in HbA1c
Time Frame: from baseline to 12 week
Change in HbA1c from baseline to 12 weeks.Unit:%
from baseline to 12 week
Change in total cholesterol
Time Frame: from baseline to 12 weeks
Changes in total cholesterol from baseline to 12 weeks. unit: mg/dL
from baseline to 12 weeks
Change in AST
Time Frame: from baseline to 12 weeks
Changes in AST from baseline to 12 weeks.unit: U/L
from baseline to 12 weeks
Change in Body fat mass
Time Frame: from baseline to 12 weeks
Changes in body fat mass from baseline to 12 weeks. unit : kg
from baseline to 12 weeks
Change in skeletal muscle mass
Time Frame: from baseline to 12 weeks
Changes in skeletal muscle mass from baseline to 12 weeks. unit:kg
from baseline to 12 weeks
Change in percent body fat
Time Frame: from baseline to 12 weeks.
Changes in percent body fat from baseline to 12 weeks. unit:%
from baseline to 12 weeks.
Change in body weight (kg)
Time Frame: from baseline to 12 weeks
Change in body weight from baseline to 12 weeks unit: kg
from baseline to 12 weeks
Changes in LDL cholesterol
Time Frame: from baseline to 12 weeks
Changes in LDL cholesterol from baseline to 12 weeks. unit: mg/dL
from baseline to 12 weeks
Changes in HDL cholesterol
Time Frame: from baseline to 12 weeks
Changes in HDL cholesterol from baseline to 12 weeks. unit: mg/dL
from baseline to 12 weeks
Changes in triglycerides
Time Frame: from baseline to 12 weeks.
Changes in triglycerides from baseline to 12 weeks.
from baseline to 12 weeks.
Changes in ALT
Time Frame: from baseline to 12 weeks
Changes in ALT from baseline to 12 weeks.unit: U/L
from baseline to 12 weeks
Changes in γ-GTP
Time Frame: from baseline to 12 weeks
Changes in γ-GTP from baseline to 12 weeks.unit: U/L
from baseline to 12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Agriculture, Food and Rural Affairs

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-2602-154-1723 (Other Identifier: Seoul National University Hospital IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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