ObesityUFA-Preserved2NCT03966755
Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF
A study testing UFA dietary recommendations in people with Obesity and Heart Failure With Normal Ejection Fraction, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study is designed to evaluate the effects of a diet rich in unsaturated fatty acids (UFA)-also known as 'healthy fats'-in patients with obesity and heart failure with preserved ejection fraction (HFpEF) on dietary consumption of UFA as well as fatty acids plasma levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Heart Failure With Normal Ejection Fraction
- What is being tested?
- UFA dietary recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 11 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Major Inclusion Criteria:
- Body Mass Index (BMI) ≥30 kg/m2 (obesity) or total body fat percentage >25% in men and >35% in women
- A confirmed clinical diagnosis of stable HF (New York Heart Association (NYHA) class II-III) on maximally tolerated heart failure (HF) optimal medical regimen (without major changes in the prior month)
- Left Ventricular Ejection Fraction (LVEF)>50% documented in the prior 12 months
Major Exclusion Criteria:
- Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e.,physical inability to walk or run on treadmill);
- Significant ischemic heart disease, angina, uncontrolled arterial hypertension, atrial fibrillation, moderate to severe valvular disease, chronic pulmonary disease, anemia (Hemoglobin<10 g/dL)
- Electrocardiography (ECG) changes (ischemia or arrhythmias) that limit maximum exertion during cardiopulmonary exercise test
- Comorbidity limiting survival
- Stage IV-V kidney disease (estimated Glomerular Filtration Rate<30)
- Fluid overload
- Pregnancy
- Current use of unsaturated fatty acids (UFA) supplement (i.e., omega-3).
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Patients With Obesity and Heart Failure With Preserved Ejection Fraction: The UFA-Preserved2 Study
This study is designed to evaluate the effects of a diet rich in unsaturated fatty acids (UFA)-also known as 'healthy fats'-in patients with obesity and heart failure with preserved ejection fraction (HFpEF) on dietary consumption of UFA as well as fatty acids plasma levels.
Read the detailed description
The study will evaluate participant's food consumption during 2 different 12-week periods. During one of the 12-week periods, participants will receive specific counseling and instructions on how to increase the consumption of food rich in healthy fats; during the other 12-week period they will receive general dietary recommendations following the Dietary Guidelines for Americans. There will be a 6-week break (washout) between the 12-week periods for a total of study period of 30 weeks. During each 12-week periods, the study will measure the effects of these dietary recommendations on dietary consumption and the fatty acids in their blood (primary endpoints).
- Being tested
- UFA dietary recommendations
- Keywords
- Obesity, Heart failure with Normal Ejection Fraction, HFpEF, unsaturated fatty acids, cardiorespiratory fitness, dietary intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFA dietary recommendationsBehavioural
The face-to-face intervention will be performed by a research nutritionist that reviews the dietary recall and provides a list of commonly available foods rich in unsaturated fatty acids (UFA) (monounsaturated fatty acids (MUFA) and polyunsaturated fatty acids (PUFA)), together with individual instructions on how to integrate the recommended foods in the daily dietary pattern based on the dietary recall, and also to emphasize that the recommended food should be consumed as listed, and not as part of processed food (i.e., guacamole for avocado, hazelnut chocolate for nuts, pesto for olive oil, fish sticks for fatty fish). Extra-virgin olive oil or canola oil or nuts will be considered first choice for daily consumption of UFA-rich food, but a list of daily food substitutes will be also provided .
| Study group | Role | What they receive |
|---|---|---|
| UFA dietary recommendations | Experimental | Dietary intervention aimed at increasing UFA consumption. Receives: Behavioral: UFA dietary recommendations |
| Standard dietary recommendations | No intervention | Standard of care dietary recommendations as currently performed in the clinic (2015-2020 United States Department of Agriculture (USDA) Dietary Guidelines for Americans) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour dietary recall
Measured with validated 24-hour dietary recall (non-self administered)
Measured: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
Change in dietary compliance (biomarkers)
Measured by changes in biomarkers of unsaturated fatty acid consumption
Measured: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start23 Jul 2019
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Salvatore Carbone, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966755
- Sponsor's protocol ID
- HM20016253
- Acronym
- UFA-Preserved2
- Status last verified
- Jul 2024
- First submitted
- 24 May 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Patients With Obesity and Heart Failure With Preserved Ejection Fraction: The UFA-Preserved2 Study
- ClinicalTrials.gov ID
- NCT03966755
- Acronym / sponsor ID
- UFA-Preserved2 / HM20016253
- Keywords
- Obesity, Heart failure with Normal Ejection Fraction, HFpEF, unsaturated fatty acids, cardiorespiratory fitness, dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 29 May 2019 (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.
This study is designed to evaluate the effects of a diet rich in unsaturated fatty acids (UFA)-also known as 'healthy fats'-in patients with obesity and heart failure with preserved ejection fraction (HFpEF) on dietary consumption of UFA as well as fatty acids plasma levels.
Detailed description
The study will evaluate participant's food consumption during 2 different 12-week periods. During one of the 12-week periods, participants will receive specific counseling and instructions on how to increase the consumption of food rich in healthy fats; during the other 12-week period they will receive general dietary recommendations following the Dietary Guidelines for Americans. There will be a 6-week break (washout) between the 12-week periods for a total of study period of 30 weeks. During each 12-week periods, the study will measure the effects of these dietary recommendations on dietary consumption and the fatty acids in their blood (primary endpoints).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UFA dietary recommendations | Experimental | Behavioral: UFA dietary recommendationsDietary intervention aimed at increasing UFA consumption. |
| Standard dietary recommendations | No intervention | –Standard of care dietary recommendations as currently performed in the clinic (2015-2020 United States Department of Agriculture (USDA) Dietary Guidelines for Americans) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| UFA dietary recommendationsThe face-to-face intervention will be performed by a research nutritionist that reviews the dietary recall and provides a list of commonly available foods rich in unsaturated fatty acids (UFA) (monounsaturated fatty acids (MUFA) and polyunsaturated fatty acids (PUFA)), together with individual instructions on how to integrate the recommended foods in the daily dietary pattern based on the dietary recall, and also to emphasize that the recommended food should be consumed as listed, and not as part of processed food (i.e., guacamole for avocado, hazelnut chocolate for nuts, pesto for olive oil, fish sticks for fatty fish). Extra-virgin olive oil or canola oil or nuts will be considered first choice for daily consumption of UFA-rich food, but a list of daily food substitutes will be also provided . | Behavioural | UFA dietary recommendations |
Primary outcome
Change in 24-hour dietary recall
Time frame: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
Measured with validated 24-hour dietary recall (non-self administered)
Change in dietary compliance (biomarkers)
Time frame: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
Measured by changes in biomarkers of unsaturated fatty acid consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Salvatore Carbone, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UFA dietary recommendations in people with Obesity and Heart Failure With Normal Ejection Fraction, run by Virginia Commonwealth University 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?
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: finished, as of the sponsor's last update on 3 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour dietary recall (time frame: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks). 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 3 Jul 2024.