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NCT Number: NCT07638241

Agentic AI Personalized Dietary Management Study

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.

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Key information

Conditions

Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Static AI-based personalized dietary goal setting

Behavioral

The AI algorithm generates individualized dietary goals based on baseline information. The generated goals are maintained without dynamic adjustment during the intervention period.

Adaptive AI-based personalized dietary management

Behavioral

The AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Change in Body Mass Index

    Time frame: Baseline and 12 weeks

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

  2. Change in Waist Circumference

    Time frame: from baseline to 12 weeks

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

  3. Change in Systolic Blood Pressure

    Time frame: from baseline to 12 weeks.

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

  4. Change in Diastolic Blood Pressure

    Time frame: from baseline to 12 week

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

  5. Change in Fasting Glucose

    Time frame: from baseline to 12 weeks.

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

  6. Change in HbA1c

    Time frame: from baseline to 12 week

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

  7. Change in total cholesterol

    Time frame: from baseline to 12 weeks

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

  8. Change in AST

    Time frame: from baseline to 12 weeks

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

  9. Change in Body fat mass

    Time frame: from baseline to 12 weeks

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

  10. Change in skeletal muscle mass

    Time frame: from baseline to 12 weeks

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

  11. Change in percent body fat

    Time frame: from baseline to 12 weeks.

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

  12. Change in body weight (kg)

    Time frame: from baseline to 12 weeks

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

  13. Changes in LDL cholesterol

    Time frame: from baseline to 12 weeks

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

  14. Changes in HDL cholesterol

    Time frame: from baseline to 12 weeks

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

  15. Changes in triglycerides

    Time frame: from baseline to 12 weeks.

    Changes in triglycerides from baseline to 12 weeks.

  16. Changes in ALT

    Time frame: from baseline to 12 weeks

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

  17. Changes in γ-GTP

    Time frame: from baseline to 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Suyeon Choi, MD, PhD

CONTACT

[email protected]

02-2112-5639

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University

Registry information

Official study title

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

Acronym: AIDiet

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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