Sodium Reduction Program Incorporating Genetic Profile and an AI-Based App: A Randomized Clinical Trial.

Abstract

Excess salt intake is a major modifiable risk factor for hypertension and cardiovascular disease. Personalized interventions using genetic information and digital tools, such as smartphone applications, may enhance sodium reduction, but evidence remains limited. To evaluate the effectiveness of a sodium reduction program incorporating a genetic profile and an artificial intelligence (AI)-based mobile app among adults with elevated blood pressure and a sodium-sensitive genotype. A 3-arm randomized clinical trial, conducted at a Japanese electronics company from September 17 to December 16, 2024, included employees aged 20 to 65 years with elevated blood pressure and the sodium-sensitive AGT M235T genotype. Participants were randomized on a 1:1:0.2 basis to (1) a treatment group receiving a genetic profile and an AI-based app incorporating sodium-specific information; (2) a control group receiving no intervention; or (3) an app-only group using the app without a genetic profile or information. The primary outcome was daily salt intake, estimated from spot urine samples using the INTERSALT (International Study of Electrolyte Excretion and Blood Pressure) formula. Secondary outcomes included self-reported body mass index, behavior change intentions, and systolic and diastolic blood pressure. Analysis was performed on an intention-to-treat basis. Of 312 randomized participants, 289 completed follow-up (mean [SD] age, 51.3 [8.3] years; 252 of 279 men [90.3%]). The mean (SD) baseline salt intake was 11.3 (2.0) g/d. At 3 months, no significant difference in salt intake was observed between the treatment and control groups (mean difference, -0.2 g/d; 95% CI, -0.7 to 0.3 g/d) or between the treatment and app-only groups (mean difference, -0.04 g/d; 95% CI, -0.9 to 0.8 g/d). No significant differences were observed between groups in any secondary outcomes. In this randomized clinical trial conducted among individuals with elevated blood pressure and a sodium-sensitive genotype, a sodium reduction program combining a genetic profile and an AI-based app with sodium-specific information did not significantly reduce salt intake. These findings highlight the challenges of achieving dietary behavior change through genetic personalized plus digital interventions. http://umin.ac.jp/ctr Identifier: UMIN000052685.