Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome RiskAIDietNCT07638241
Agentic AI Personalized Dietary Management Study
A study testing Static AI-based personalized dietary goal setting and Adaptive AI-based personalized dietary management in people with Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk
- What is being tested?
- Static AI-based personalized dietary goal setting and Adaptive AI-based personalized dietary management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital Healthcare System Gangnam Center
Seoul, Seoul, 06236
Su-Yeon Choi, PhD, +82-10-2028-5782, 65390@snuh.org
About this study
Official title: 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.
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.
- Conditions
- Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk
- Being tested
- Static AI-based personalized dietary goal setting, Adaptive AI-based personalized dietary management
- Keywords
- Agentic AI; Personalized Nutrition; Digital Health; AI Coaching; Precision Nutrition; Dietary Management; Health Screening
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static AI-based personalized dietary goal settingBehavioural
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 managementBehavioural
The AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants receive standard dietary education and perform passive dietary recording during the 12-week study period. |
| Static goal AI intervention group | Experimental | Participants receive AI-generated personalized dietary goals that are maintained during the 12-week intervention period. Receives: Behavioral: Static AI-based personalized dietary goal setting |
| Adaptive goal AI intervention group | Experimental | Participants receive adaptive AI-based dietary tracking, dynamic goal adjustment, and personalized feedback during the 12-week intervention period. Receives: Behavioral: Adaptive AI-based personalized dietary management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 12 weeks
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
Measured: from baseline to 12 weeks.
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
Measured: from baseline to 12 weeks
Secondary outcomes (17)
Change in Body Mass Index
Change in body mass index from baseline to 12 weeks. Unit: kg/m²
Measured: Baseline and 12 weeks
Change in Waist Circumference
Change in waist circumference from baseline to 12 weeks. Unit : cm
Measured: from baseline to 12 weeks
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline to 12 weeks.Unit:mmHg
Measured: from baseline to 12 weeks.
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline to 12 weeks. Unit:mmHg
Measured: from baseline to 12 week
Change in Fasting Glucose
Change in fasting glucose from baseline to 12 weeks. Unit:mg/dL
Measured: from baseline to 12 weeks.
Change in HbA1c
Change in HbA1c from baseline to 12 weeks.Unit:%
Measured: from baseline to 12 week
Change in total cholesterol
Changes in total cholesterol from baseline to 12 weeks. unit: mg/dL
Measured: from baseline to 12 weeks
Change in AST
Changes in AST from baseline to 12 weeks.unit: U/L
Measured: from baseline to 12 weeks
Change in Body fat mass
Changes in body fat mass from baseline to 12 weeks. unit : kg
Measured: from baseline to 12 weeks
Change in skeletal muscle mass
Changes in skeletal muscle mass from baseline to 12 weeks. unit:kg
Measured: from baseline to 12 weeks
Change in percent body fat
Changes in percent body fat from baseline to 12 weeks. unit:%
Measured: from baseline to 12 weeks.
Change in body weight (kg)
Change in body weight from baseline to 12 weeks unit: kg
Measured: from baseline to 12 weeks
Changes in LDL cholesterol
Changes in LDL cholesterol from baseline to 12 weeks. unit: mg/dL
Measured: from baseline to 12 weeks
Changes in HDL cholesterol
Changes in HDL cholesterol from baseline to 12 weeks. unit: mg/dL
Measured: from baseline to 12 weeks
Changes in triglycerides
Changes in triglycerides from baseline to 12 weeks.
Measured: from baseline to 12 weeks.
Changes in ALT
Changes in ALT from baseline to 12 weeks.unit: U/L
Measured: from baseline to 12 weeks
Changes in γ-GTP
Changes in γ-GTP from baseline to 12 weeks.unit: U/L
Measured: from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start11 Jun 2026
- Primary completion26 Feb 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome RiskStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an AI-based personalized dietary management intervention group or a control group receiving standard nutritional information. The study will be conducted in a parallel-group design to evaluate the effectiveness of the intervention on metabolic health and dietary behaviors.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Agriculture, Food and Rural Affairs
- Responsible party
- Principal investigator, Su-Yeon Choi, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638241
- Sponsor's protocol ID
- H-2602-154-1723
- Other IDs
- H-2602-154-1723
- Acronym
- AIDiet
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Agentic AI-Based Personalized Dietary Management Algorithm in Health Screening Participants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07638241
- Acronym / sponsor ID
- AIDiet / H-2602-154-1723
- Conditions
- Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk
- Keywords
- Agentic AI; Personalized Nutrition; Digital Health; AI Coaching; Precision Nutrition; Dietary Management; Health Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Agriculture, Food and Rural Affairs
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to either an AI-based personalized dietary management intervention group or a control group receiving standard nutritional information. The study will be conducted in a parallel-group design to evaluate the effectiveness of the intervention on metabolic health and dietary behaviors.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants receive standard dietary education and perform passive dietary recording during the 12-week study period. |
| Static goal AI intervention group | Experimental | Behavioral: Static AI-based personalized dietary goal settingParticipants receive AI-generated personalized dietary goals that are maintained during the 12-week intervention period. |
| Adaptive goal AI intervention group | Experimental | Behavioral: Adaptive AI-based personalized dietary managementParticipants receive adaptive AI-based dietary tracking, dynamic goal adjustment, and personalized feedback during the 12-week intervention period. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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]
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static AI-based personalized dietary goal settingThe AI algorithm generates individualized dietary goals based on baseline information. The generated goals are maintained without dynamic adjustment during the intervention period. | Behavioural | Static goal AI intervention group |
| Adaptive AI-based personalized dietary managementThe AI algorithm monitors dietary records and relevant participant information, adjusts dietary goals dynamically, and provides personalized feedback to support dietary behavior change. | Behavioural | Adaptive goal AI intervention group |
Primary outcome
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
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
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
17 secondary outcomes
Change in Body Mass Index
Time frame: Baseline and 12 weeks
Change in Waist Circumference
Time frame: from baseline to 12 weeks
Change in Systolic Blood Pressure
Time frame: from baseline to 12 weeks.
Change in Diastolic Blood Pressure
Time frame: from baseline to 12 week
Change in Fasting Glucose
Time frame: from baseline to 12 weeks.
Change in HbA1c
Time frame: from baseline to 12 week
Change in total cholesterol
Time frame: from baseline to 12 weeks
Change in AST
Time frame: from baseline to 12 weeks
Change in Body fat mass
Time frame: from baseline to 12 weeks
Change in skeletal muscle mass
Time frame: from baseline to 12 weeks
Change in percent body fat
Time frame: from baseline to 12 weeks.
Change in body weight (kg)
Time frame: from baseline to 12 weeks
Changes in LDL cholesterol
Time frame: from baseline to 12 weeks
Changes in HDL cholesterol
Time frame: from baseline to 12 weeks
Changes in triglycerides
Time frame: from baseline to 12 weeks.
Changes in ALT
Time frame: from baseline to 12 weeks
Changes in γ-GTP
Time frame: from baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static AI-based personalized dietary goal setting and Adaptive AI-based personalized dietary management in people with Dietary Behavior; Metabolic Health; Obesity; Lifestyle Modification; Metabolic Syndrome Risk, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suyeon Choi, MD, PhD (02-2112-5639, 65390@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Behavior Score (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.