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Life sciences · Observational Study
ClinicalTrials.gov · September 28, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07649148). This is a study registration, not published results. Lead sponsor: The Cleveland Clinic. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Heart Failure, NYHA Class II Heart Failure, NYHA Class III Heart Failure. Interventions: BEHAVIORAL: Limiting Ultraprocessed Food (UPF) in Diet. Primary outcome measures: Document Ultraprocessed Food (UPF) Consumption in HF , 5 years; Change in ultraprocessed food (UPF) consumption in heart failure patients , 5 Years. Brief 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.