Dietary Tracking in Heart Failure

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07649148
Status
Recruiting

Conditions

  • Heart Failure
  • NYHA Class II Heart Failure
  • NYHA Class III Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Limiting Ultraprocessed Food (UPF) in Diet — BEHAVIORAL
    Participants in this study will be advised on ways to limit UPF in their diet for a period of 28 days. There is no specific diet to follow. Instead, researchers will ask participants to track what they eat in a mobile app (Cronometer) with the aim of reducing UPF consumption.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2036
Completion
Jun 30, 2040

Study Design

Enrollment
60 participants (estimated)

Primary Outcome Measure

Document Ultraprocessed Food (UPF) Consumption in HF [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Main CampusClevelandOhio44195
Valesha Province, MS
216-636-6153
Jeniffer Wilcox
216-636-6153
W. H. Wilson Tang, MD (PRINCIPAL_INVESTIGATOR)

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