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Not yet recruitingNCT07649148DOTTIEUpdated Sep 28, 2026

Dietary Tracking in Heart Failure

An observational study in Heart Failure, NYHA Class II Heart Failure and NYHA Class III Heart Failure, sponsored by The Cleveland Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure
  • NYHA Class II Heart Failure
  • NYHA Class III Heart Failure

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Keywords

  • Diet Tracking
  • Diet
  • Heart Failure
  • Cronometer
  • Ultra Processed Food
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

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.

05

What researchers measure

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

06

Study locations

1 site
  • Cleveland Clinic Main Campus
    Cleveland, Ohio 44195, United States
    • Valesha Province, MS · Contact · provinv@ccf.org · 216-636-6153
    • Jeniffer Wilcox · Contact · kirsopj@ccf.org · 216-636-6153
    • W. H. Wilson Tang, MD · Principal investigator
07

References and documents

Individual participant data

Plan to share: No — Data will only be shared in aggregate and deidentified.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07649148
Lead sponsor
The Cleveland Clinic
Responsible party
Wilson Tang (Staff, Section of Heart Failure and Cardiac Transplantation Medicine & Staff, Cleveland Clinic Research, The Cleveland Clinic) — Principal investigator
First posted
Jun 16, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2036 (estimated)
Completion
Dec 2040 (estimated)
Last update
Sep 28, 2026

Study contacts

Valesha Province, MS
Contact
provinv@ccf.org
216-636-6153
Jennifer Wilcox
Contact
kirsopj@ccf.org
216-636-6153
W. H. Wilson Tang, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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