title: The NUTRAOLEOUM Study, a randomized controlled trial, for achieving nutritional added value for olive oils.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The Trial has been registered in ClinicalTrials.gov ID: NCT02520739 .
authors: Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía Oriental "Alejandro Otero" (FIBAO), Granada, Spain.
authors: Sara
authors: S
authors: Biel
authors: Instituto de Nutrición y Tecnología de Alimentos "José Mataix" (INyTA), Granada, Spain.
authors: Maria-Dolores
authors: MD
authors: Mesa
authors: Integrative Pharmacology and Neurosciences Systems Research Group and Cardiovascular Risk and Nutrition Research Group. Hospital del Mar Research Institute (IMIM), Barcelona, Spain.|Spanish Biomedical ResearchNetworking Centre, Physiopathology of Obesity and Nutrition (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain.|Universitat Pompeu Fabra, (CEXS-UPF), Barcelona, Spain.
authors: Rafael
authors: R
authors: de la Torre
authors: Instituto para la Calidad y Seguridad Alimentaria (ICSA), Granada, Spain.
authors: Juan-Antonio
authors: JA
authors: Espejo
authors: Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía Oriental "Alejandro Otero" (FIBAO), Granada, Spain.
authors: Jose-Ramón
authors: JR
authors: Fernández-Navarro
authors: Integrative Pharmacology and Neurosciences Systems Research Group and Cardiovascular Risk and Nutrition Research Group. Hospital del Mar Research Institute (IMIM), Barcelona, Spain.|Spanish Biomedical ResearchNetworking Centre, Physiopathology of Obesity and Nutrition (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain.
authors: Montserrat
authors: M
authors: Fitó
authors: Instituto de Nutrición y Tecnología de Alimentos "José Mataix" (INyTA), Granada, Spain.
authors: Estefanía
authors: E
authors: Sánchez-Rodriguez
authors: Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía Oriental "Alejandro Otero" (FIBAO), Granada, Spain.
authors: Carmen
authors: C
authors: Rosa
authors: CM EUROPA, Jaen, Spain.
authors: Rosa
authors: R
authors: Marchal
authors: Biologia Reproductiva de Plantas. Consejo Superior de Investigaciones Científicas (CSIC), Granada, Spain.
authors: Juan de Dios
authors: JD
authors: Alche
authors: Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía Oriental "Alejandro Otero" (FIBAO), Granada, Spain.
authors: Manuela
authors: M
authors: Expósito
authors: Antimicrobianos Naturales. Biotecnología de los Alimentos. Instituto de la Grasa, Consejo Superior de Investigaciones Científicas (CSIC), Sevilla, Spain.
authors: Manuel
authors: M
authors: Brenes
authors: Química y Bioquímica de Pigmentos. Fitoquímica de los Alimentos. Instituto de la Grasa. Consejo Superior de Investigaciones Científicas (CSIC), Sevilla, Spain.
authors: Beatriz
authors: B
authors: Gandul
authors: Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía Oriental "Alejandro Otero" (FIBAO), Granada, Spain.
authors: Miguel Angel
authors: MA
authors: Calleja
authors: NUPROAS Handelsbolag, Nackã, Sweden. maria.nuproas@gmail.com.|NUPROAS HB, Spanish Office: Apartado de Correos 93, 17242, Girona, Spain. maria.nuproas@gmail.com.
authors: María-Isabel
authors: MI
authors: Covas
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood; D004249:DNA Damage / Q000187:drug effects; D055951:Functional Food; D006801:Humans; D007249:Inflammation / Q000378:metabolism; D050356:Lipid Metabolism / Q000187:drug effects; D008875:Middle Aged; D000069463:Olive Oil / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology; D010084:Oxidation-Reduction / Q000187:drug effects; D010636:Phenols / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology; D014315:Triterpenes / Q000008:administration & dosage / Q000737:chemistry / Q000494:pharmacology; D055815:Young Adult
chemical_list: D015415:Biomarkers; D000069463:Olive Oil; D010636:Phenols; D014315:Triterpenes
keywords: Functional olive oil; Maslinic acid; Oleanolic acid; Olive oil; Olive oil polyphenols; Virgin olive oil