Heart FailureDOTTIENCT07649148
Dietary Tracking in Heart Failure
An observational study of Heart Failure and NYHA Class II Heart Failure, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, NYHA Class II Heart Failure, NYHA Class III Heart Failure
- What is being tested?
- Limiting Ultraprocessed Food (UPF) in Diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with NYHA Class II-III Heart Failure willing and able to track their diet using a mobile app.
Who may be able to join
- 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)
Who cannot join
- History of heart transplant or LVAD implant
- Unable or unwilling to follow dietary coaching for UPF reduction
- eGFR <30 ml/kg/1.73m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Valesha Province, MS, 216-636-6153, provinv@ccf.org
Jeniffer Wilcox, 216-636-6153, kirsopj@ccf.org
About this study
Official title: 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.
- Being tested
- Limiting Ultraprocessed Food (UPF) in Diet
- Keywords
- Diet Tracking, Diet, Heart Failure, Cronometer, Ultra Processed Food
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limiting Ultraprocessed Food (UPF) in DietBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Document Ultraprocessed Food (UPF) Consumption in HF
To improve understanding of UPF consumption (type(s), amount(s), etc.) in patients with heart failure
Measured: 5 years
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.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2036 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Tang, The Cleveland Clinic
- Investigators
- W. H. Wilson Tang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649148
- Sponsor's protocol ID
- 26-571
- Acronym
- DOTTIE
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be shared in aggregate and deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Optimization Through Tracking and Integrated Evaluation
- ClinicalTrials.gov ID
- NCT07649148
- Acronym / sponsor ID
- DOTTIE / 26-571
- Keywords
- Diet Tracking, Diet, Heart Failure, Cronometer, Ultra Processed Food
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with NYHA Class II-III Heart Failure willing and able to track their diet using a mobile app.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- History of heart transplant or LVAD implant
- Unable or unwilling to follow dietary coaching for UPF reduction
- eGFR <30 ml/kg/1.73m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limiting Ultraprocessed Food (UPF) in DietParticipants 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. | Behavioural | – |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. Data will only be shared in aggregate and deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
W. H. Wilson Tang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and NYHA Class II Heart Failure, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valesha Province, MS (216-636-6153, provinv@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document Ultraprocessed Food (UPF) Consumption in HF (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.