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NCT07649148Recruiting

Dietary Tracking in Heart Failure

The Cleveland Clinic

Start Date

6/1/2026

Completion Date

6/1/2040

Summary

Emerging evidence links ultra processed foods (UPFs) to adverse cardiovascular outcomes. UPFs are often high in sodium, unhealthy fats and added sugars, while being low in essential nutrients and fiber. UPFs contribute to systemic inflammation, fluid retention, and metabolic dysfunction-key drivers of HF and kidney disease progression. Traditional dietary counseling often lacks specificity around food processing levels. Furthermore, the majority of nutrition studies relied on extensive self-reported dietary recall food frequency questionnaires (FFQ) that are subjective, often labor intensive, and difficult to implement practically in the clinical setting. As such, researchers have developed metabolite scores from blood and urine samples to help quantify UPF consumption, which has the promise to better guide dietary counseling and track process. Therefore, the aim of this study is to evaluate the feasibility and physiological impact of a structured UPF-reduction dietary intervention in patients with HF, leveraging both digital dietary tools (Cronometer) and biomarker assessments.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adults (≥18 years) with NYHA Class II-III HF * Able to use Cronometer to track dietary intake and able to prepare food at home independently (able to modify dietary intake) Exclusion Criteria: * History of heart transplant or LVAD implant * Unable or unwilling to follow dietary coaching for UPF reduction * eGFR \<30 ml/kg/1.73m2

Interventions

BEHAVIORAL

Limiting Ultraprocessed Food (UPF) in Diet

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Conditions

Heart FailureNYHA Class II Heart FailureNYHA Class III Heart Failure

Locations

Cleveland Clinic Main Campus

Cleveland, Ohio 44195

United States