@misc{10481/96520, year = {2016}, url = {https://hdl.handle.net/10481/96520}, abstract = {Abstract Background: Virgin olive oil, a recognized healthy food, cannot be consumed in great quantities. We aim to assess in humans whether an optimized virgin olive oil with high phenolic content (OVOO, 429 mg/Kg) and a functional one (FOO), both rich in phenolic compounds (429 mg/Kg) and triterpenic acids (389 mg/kg), could provide health benefits additional to those supplied a by a standard virgin olive oil (VOO). Methods/design: A randomized, double-blind, crossover, controlled study will be conducted. Healthy volunteers (aged 20 to 50) will be randomized into one of three groups of daily raw olive oil consumption: VOO, OVOO, and FOO (30 mL/d). Olive oils will be administered over 3-week periods preceded by 2-week washout ones. The main outcomes will be markers of lipid and DNA oxidation, inflammation, and vascular damage. A bioavailability and dose-response study will be nested within this sustained- consumption one. It will be made up of 18 volunteers and be performed at two stages after a single dose of each olive oil. Endothelial function and nitric oxide will be assessed at baseline and at 4 h and 6 h after olive oil single dose ingestion. Discussion: For the first time the NUTRAOLEUM Study will provide first level evidence on the health benefits in vivo in humans of olive oil triterpenes (oleanolic and maslinic acid) in addition to their bioavailability and disposition. Trial registration: The Trial has been registered in ClinicalTrials.gov ID: NCT02520739. Keywords: Olive oil, Virgin olive oil, Functional olive oil, Olive oil polyphenols, Maslinic acid, Oleanolic acid}, organization = {The NUTRAOLEOUM Study has been supported by the grant ITC-20131031 from the FEDER-INTERCONNECTA (CDTI) and Junta de Andalucía, Spain. We thank ACER CAMPESTRES, San Francisco de Asis Coop. And., and AGROINSUR SL, for providing the materials and processes for obtaining the olive oils used in the Project. These sources do not have any rol or authority in the in study design; collection, management, analyses, and interpretation of data; writing or submission of the report}, publisher = {BIOMED CENTRAL LTD}, keywords = {olive oil}, keywords = {virgin olive oil}, keywords = {functional olive oil}, keywords = {Olive oil polyphenols}, keywords = {Maslinic acid}, keywords = {Oleanolic acid}, title = {The NUTRAOLEOUM Study, a randomized controlled trial, for achieving nutritional added value for olive oils}, doi = {10.1186/s12906-016-1376-6}, author = {Mesa García, María Dolores and Torre, Rafael de la and Biel Gibson, Sara and Espejo, Juan Antonio and Fernández Navarro, Juan Antonio and Fitó, Montserrat and Sánchez-Rodriguez, Estefanía and Rosa, Carmen and Marchal, Rosa and Alche, Juan de Dios and Expósito Ruiz, Manuela and Brenes, Manuel and Gandul, Beatriz and Calleja Hernández, Miguel Ángel and Covas, María Isabel}, }