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NCT Number: NCT07649148

Dietary Tracking in Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases NYHA Class II Heart Failure NYHA Class III Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Document Ultraprocessed Food (UPF) Consumption in HF

    Time frame: 5 years

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

  2. Change in ultraprocessed food (UPF) consumption in heart failure patients

    Time frame: 5 Years

    To investigate the potential for reducing UPF consumption via dietary counseling, Cronometer tracking, and structured patient feedback.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Wilcox

CONTACT

[email protected]

216-636-6153

Valesha Province, MS

CONTACT

[email protected]

216-636-6153

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Dietary Optimization Through Tracking and Integrated Evaluation

Acronym: DOTTIE

Important dates

Study start
2026
Primary completion
2036
Study completion
2040
First posted
Jun 16, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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