Clinical Trial

Dietary Tracking in Heart Failure

Study acronym: DOTTIE
Recruiting
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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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-06-18
Trial Details
NCT Number NCT07649148
Lead Sponsor The Cleveland Clinic
Conditions Heart Failure, NYHA Class II Heart Failure, NYHA Class III Heart Failure
Enrollment 60 participants
Start Date 2026-06
Primary Completion 2036-06 (estimated)
Study Completion 2040-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-17