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Dietary Tracking in Heart Failure

Study acronym: DOTTIE
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2036 → Dec 2036
See other at-risk trials from The Cleveland Clinic

Record History

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  1. Notable Start date: Jun 2026 to Dec 2026 Show 5 more changesShow less
    • Trial status changed: Recruiting → Not Yet Recruiting
    • Primary completion pushed from Jun 2036 to Dec 2036
    • Study completion pushed from Jun 2040 to Dec 2040
    • Site details revised
    • Eligibility criteria expanded, about 5 words
  2. Notable Primary endpoint(s) modifiedv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
8,786 trials monitored
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1,995 trials monitored
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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.
Trial Details
NCT Number NCT07649148
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)
Heart Failure, NYHA Class II Heart Failure, NYHA Class III Heart Failure
Related terms Heart Failure
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov