Recruiting

UPF-Reduction Diet

Sponsor:

The Cleveland Clinic

Code:

NCT07649148

Conditions

Heart Failure

NYHA Class II Heart Failure

NYHA Class III Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Limiting Ultraprocessed Food (UPF) in Diet

Study Details

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

Study ID

NCT07649148

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2040

Anticipated

Primary completion date

Jun, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

Limiting 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.

Primary outcome measure

  • Document Ultraprocessed Food (UPF) Consumption in HF [ Time Frame: 5 years ]
  • Change in ultraprocessed food (UPF) consumption in heart failure patients [ Time Frame: 5 Years ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

W. H. Wilson Tang, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-17.