Dietary Tracking in Heart Failure

NCT07649148 | Recruiting

• 1 other identifier: 26-571
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; NYHA Class II Heart Failure; NYHA Class III Heart Failure

Keywords

Diet Tracking; Diet; Heart Failure; Cronometer; Ultra Processed Food

Outcome Measures

Primary Outcomes (2)

• Document Ultraprocessed Food (UPF) Consumption in HF

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

  5 years

• 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.

  5 Years

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• History of heart transplant or LVAD implant
• Unable or unwilling to follow dietary coaching for UPF reduction
• eGFR \<30 ml/kg/1.73m2

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• W. H. Wilson Tang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valesha Province, MS

CONTACT

216-636-6153; provinv@ccf.org

Jennifer Wilcox

CONTACT

216-636-6153; kirsopj@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, Section of Heart Failure and Cardiac Transplantation Medicine & Staff, Cleveland Clinic Research

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): June 1, 2040
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)