Dietary Tracking in Heart Failure

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

History of heart transplant or LVAD implant

Unable or unwilling to follow dietary coaching for UPF reduction

eGFR <30 ml/kg/1.73m2

Trial population

Adults with NYHA Class II-III Heart Failure willing and able to track their diet using a mobile app.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Document Ultraprocessed Food (UPF) Consumption in HF

To improve understanding of UPF consumption (type(s), amount(s), etc.) in patients with heart failure

Time frame
5 years
2

Change in ultraprocessed food (UPF) consumption in heart failure patients

To investigate the potential for reducing UPF consumption via dietary counseling, Cronometer tracking, and structured patient feedback.

Time frame
5 Years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: