CClinicalTrials.gg
RecruitingNCT07638241AIDietUpdated Sep 15, 2026

Agentic AI Personalized Dietary Management Study

An interventional study of Static AI-based personalized dietary goal setting and Adaptive AI-based personalized dietary management in Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk

Browse trials for

Keywords

  • Agentic AI; Personalized Nutrition; Digital Health; AI Coaching; Precision Nutrition; Dietary Management; Health Screening
03

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralStatic 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.

  • BehavioralAdaptive 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.

05

What researchers measure

Primary outcomes

  1. Change in Dietary Behavior Score

    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

    Time frame: Baseline and 12 weeks

  2. Outcome Measure: Change in Client Satisfaction Questionnaire Score (CSQ-8)

    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

    Time frame: from baseline to 12 weeks.

  3. Change in System Usability Scale Score (SUS)

    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

    Time frame: from baseline to 12 weeks

Secondary outcomes

  1. Change in Body Mass Index

    Change in body mass index from baseline to 12 weeks. Unit: kg/m²

    Time frame: Baseline and 12 weeks

  2. Change in Waist Circumference

    Change in waist circumference from baseline to 12 weeks. Unit : cm

    Time frame: from baseline to 12 weeks

  3. Change in Systolic Blood Pressure

    Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg

    Time frame: from baseline to 12 weeks.

  4. Change in Diastolic Blood Pressure

    Change in diastolic blood pressure from baseline to 12 weeks. Unit:mmHg

    Time frame: from baseline to 12 week

  5. Change in Fasting Glucose

    Change in fasting glucose from baseline to 12 weeks. Unit:mg/dL

    Time frame: from baseline to 12 weeks.

  6. Change in HbA1c

    Change in HbA1c from baseline to 12 weeks.Unit:%

    Time frame: from baseline to 12 week

  7. Change in total cholesterol

    Changes in total cholesterol from baseline to 12 weeks. unit: mg/dL

    Time frame: from baseline to 12 weeks

  8. Change in AST

    Changes in AST from baseline to 12 weeks.unit: U/L

    Time frame: from baseline to 12 weeks

  9. Change in Body fat mass

    Changes in body fat mass from baseline to 12 weeks. unit : kg

    Time frame: from baseline to 12 weeks

  10. Change in skeletal muscle mass

    Changes in skeletal muscle mass from baseline to 12 weeks. unit:kg

    Time frame: from baseline to 12 weeks

  11. Change in percent body fat

    Changes in percent body fat from baseline to 12 weeks. unit:%

    Time frame: from baseline to 12 weeks.

  12. Change in body weight (kg)

    Change in body weight from baseline to 12 weeks unit: kg

    Time frame: from baseline to 12 weeks

  13. Changes in LDL cholesterol

    Changes in LDL cholesterol from baseline to 12 weeks. unit: mg/dL

    Time frame: from baseline to 12 weeks

  14. Changes in HDL cholesterol

    Changes in HDL cholesterol from baseline to 12 weeks. unit: mg/dL

    Time frame: from baseline to 12 weeks

  15. Changes in triglycerides

    Changes in triglycerides from baseline to 12 weeks.

    Time frame: from baseline to 12 weeks.

  16. Changes in ALT

    Changes in ALT from baseline to 12 weeks.unit: U/L

    Time frame: from baseline to 12 weeks

  17. Changes in γ-GTP

    Changes in γ-GTP from baseline to 12 weeks.unit: U/L

    Time frame: from baseline to 12 weeks

06

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital Healthcare System Gangnam Center
    Seoul, Seoul 06236, South Korea
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07638241
Lead sponsor
Seoul National University Hospital
Collaborators
Ministry of Agriculture, Food and Rural Affairs
Responsible party
Su-Yeon Choi (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 10, 2026
Start date
Jun 11, 2026
Primary completion
Feb 26, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 15, 2026

Study contacts

Suyeon Choi, MD, PhD
Contact
65390@snuh.org
02-2112-5639

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion