Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients
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|ClinicalTrials.gov Identifier: NCT03310099|
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : March 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Normal Ejection Fraction Obesity||Behavioral: Increasing daily unsaturated fatty acid consumption||Not Applicable|
Twelve obese HFpEF subjects with exercise intolerance (reduce cardiorespiratory fitness measured at maximal cardiopulmonary exercise test [CPX]) will be assigned to a single-arm open-label dietary intervention in which subjects are encouraged and financially supported to increase daily UFA consumption. The investigators will measure dietary compliance with a validated 24-hour dietary recall and with objective operator-independent biomarkers of UFA consumption.
The investigators will also measure the effects of UFA supplementation on: metabolic flexibility, glucose tolerance and body composition. Participants will have the option to participate in overnight session in the whole indirect calorimeter room (WIC) at baseline and at the end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients: a Feasibility Study|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||August 31, 2018|
Experimental: Dietary Intervention
Dietary intervention aimed at increasing UFA consumption. 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 [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 .
Behavioral: Increasing daily unsaturated fatty acid consumption
Investigators will provide participant with detailed information about the consumption of food rich in unsaturated fatty acids (UFA) like extra-virgin olive oil, canola oil or mixed nuts, and they will provide specific recommendations based on the participant's diet. The investigators will follow up with a weekly phone call to assure that the dietary recommendations are clear and that the participants can integrate the suggestions into their daily diets.
- Change in 24-hour dietary recall [ Time Frame: Baseline to 12 weeks ]Measured with validated 24-hour dietary recall (non-self administered)
- Change in dietary compliance (biomarkers) [ Time Frame: Baseline to 12 weeks ]Measured by changes in biomarkers of unsaturated fatty acid consumption
- Change in metabolic flexibility [ Time Frame: At baseline and 12 weeks ]Area under the curve change of respiratory quotient measured during overnight stay for 14 hours in the WIC
- Change in body composition [ Time Frame: At baseline and at 12 weeks ]Assessed by dual energy X-ray absorptiometry (DXA)
- Change in glucose tolerance [ Time Frame: At baseline and at 12 weeks ]Oral glucose tolerance test (OGTT) measures plasma glucose and insulin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310099
|Contact: Salvatore Carbone, PhD||(804) firstname.lastname@example.org|
|Contact: Hayley Billingsley, RD||(804) email@example.com|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Antonio Abbate, MD, PhD 804-828-0513 firstname.lastname@example.org|
|Contact: Salvatore Carbone, PhD (804) 628-3980 email@example.com|
|Principal Investigator:||Salvatore Carbone, PhD||Virginia Commonwealth University|