Virginia Commonwealth University
Richmond, Virginia, 23298, United States
NCT Number: NCT03966755
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Richmond, Virginia, 23298, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Major Inclusion Criteria:
Major Exclusion Criteria:
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 .
Time frame: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
Measured with validated 24-hour dietary recall (non-self administered)
Time frame: At baseline, at 12 weeks, at 18 weeks, and at 30 weeks
Measured by changes in biomarkers of unsaturated fatty acid consumption
Virginia Commonwealth University
Other
Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Patients With Obesity and Heart Failure With Preserved Ejection Fraction: The UFA-Preserved2 Study
Acronym: UFA-Preserved2
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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