Dietary Tracking in Heart Failure (DOTTIE)

June 15, 2026 updated by: Wilson Tang, The Cleveland Clinic

Dietary Optimization Through Tracking and Integrated Evaluation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Behavioral: Limiting Ultraprocessed Food (UPF) in Diet

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jennifer Wilcox
Phone Number: 216-636-6153
Email: kirsopj@ccf.org

Study Contact Backup

Name: Valesha Province, MS
Phone Number: 216-636-6153
Email: provinv@ccf.org

Study Locations

United States
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic Main Campus
    - Principal Investigator:
      
      W. H. Wilson Tang, MD
    - Contact:
      
      Valesha Province, MS
      
      Phone Number: 216-636-6153
      
      Email: provinv@ccf.org
    - Contact:
      
      Jeniffer Wilcox
      
      Phone Number: 216-636-6153
      
      Email: kirsopj@ccf.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years
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.	5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

Principal Investigator: W. H. Wilson Tang, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2036

Study Completion (Estimated)

June 1, 2040

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified