Heart Failure, NYHA Class II Heart Failure, NYHA Class III Heart Failure
Conditions
Keywords
Diet Tracking, Diet, Heart Failure, Cronometer, Ultra Processed Food
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.
Interventions
BEHAVIORALLimiting Ultraprocessed Food (UPF) in Diet
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.
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* History of heart transplant or LVAD implant * Unable or unwilling to follow dietary coaching for UPF reduction * eGFR \<30 ml/kg/1.73m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Document Ultraprocessed Food (UPF) Consumption in HF | 5 years | To improve understanding of UPF consumption (type(s), amount(s), etc.) in patients with heart failure |
| Change in ultraprocessed food (UPF) consumption in heart failure patients | 5 Years | To investigate the potential for reducing UPF consumption via dietary counseling, Cronometer tracking, and structured patient feedback. |
Countries
United States
Contacts
CONTACTValesha Province, MS
CONTACTJennifer Wilcox
PRINCIPAL_INVESTIGATORW. H. Wilson Tang, MD
The Cleveland Clinic
Outcome results
None listed