The NUTRAOLEOUM Study, a randomized controlled trial, for achieving nutritional added value for olive oils Mesa García, María Dolores Torre, Rafael de la Biel Gibson, Sara Espejo, Juan Antonio Fernández Navarro, Juan Antonio Fitó, Montserrat Sánchez-Rodriguez, Estefanía Rosa, Carmen Marchal, Rosa Alche, Juan de Dios Expósito Ruiz, Manuela Brenes, Manuel Gandul, Beatriz Calleja Hernández, Miguel Ángel Covas, María Isabel olive oil virgin olive oil functional olive oil Olive oil polyphenols Maslinic acid Oleanolic acid 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 2024-10-30T13:32:20Z 2024-10-30T13:32:20Z 2016 journal article Biel S, Mesa MD, de la Torre R, Espejo JA, Fernández-Navarro JR, Fitó M, Sánchez-Rodriguez E, Rosa C, Marchal R, Alche JD, Expósito M, Brenes M, Gandul B, Calleja MA, Covas MI. The NUTRAOLEOUM Study, a randomized controlled trial, for achieving nutritional added value for olive oils. BMC Complement Altern Med. 2016 Oct 22;16(1):404. doi: 10.1186/s12906-016-1376-6. PMID: 27770787; PMCID: PMC5075414. https://hdl.handle.net/10481/96520 10.1186/s12906-016-1376-6 eng open access BIOMED CENTRAL LTD