None listed
Conditions
Interventions
Dietary Supplement : The primary objective of this study is to evaluate the feasibility of applying homomorphic encryption and federated learning technologies to clinical trial screening and conduct.
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adults aged between 19 and 75 years at the time of obtaining informed consent. (2) Individuals with available health examination records obtained within the past two years (from January 1 of the year two years prior to the assessment date up to the assessment date), at the time of de-identified preliminary risk assessment. (3) Individuals with a calculated cardiovascular disease risk probability of less than 10%, based on health examination records obtained within the past two years (from January 1 of the year two years prior to the assessment date up to the assessment date). (4) Individuals capable of installing and utilizing a mobile application. (5) Individuals who have received and fully understood detailed information about this clinical study, voluntarily decided to participate, and provided informed consent prior to screening procedures.
Exclusion criteria
Exclusion criteria: (1) Presence or history of clinically significant hepatic, renal, neurological, respiratory, endocrine, hematologic/oncologic, cardiovascular, urologic, or psychiatric disorders. (2) Known allergy to green tea extract. (3) Experience of symptoms such as nervousness or insomnia after consuming =100 mg of caffeine per day (equivalent to approximately one cup of coffee). (4) Aspartate aminotransferase or alanine aminotransferase levels exceeding 1.5 times the upper limit of normal. (5) Pregnant or lactating women, or women planning pregnancy. (6) Positive results on serological testing for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV). (7) Current use or planned use of health supplements or medications related to cholesterol management during the intervention period. (8) Inability to refrain from consuming foods containing green tea or green tea extract during the intervention period. (9) Inability to maintain habitual levels of smoking, alcohol consumption, or physical activity during the intervention period. (10) Any other condition judged by the investigator to make the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discrepancy between cardiovascular disease risk estimates derived through homomorphic encryption-based computation and those obtained by direct calculation performed by the investigator;Discrepancy between the cardiovascular disease risk prediction model constructed using federated learning and the model constructed by pooling raw data across sites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides;Changes in cardiovascular disease risk probability | — |
Countries
Korea, Republic of
Contacts
Public ContactJaegu Kang
Seoul National University Hospital
Outcome results
None listed