| NCT ID | NCT07649148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06 |
| Primary Completion | 2036-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-06 with a primary completion date of 2036-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
W. H. Wilson Tang, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT07649148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07649148 currently recruiting?
Yes, NCT07649148 is actively recruiting participants. Contact the research team at provinv@ccf.org for enrollment information.
Where is the NCT07649148 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07649148 clinical trial?
NCT07649148 is sponsored by The Cleveland Clinic. The principal investigator is W. H. Wilson Tang, MD at The Cleveland Clinic. The trial plans to enroll 60 participants.
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