Biel Sara, Mesa Maria-Dolores, de la Torre Rafael, Espejo Juan-Antonio, Fernández-Navarro Jose-Ramón, Fitó Montserrat, Sánchez-Rodriguez Estefanía, Rosa Carmen, Marchal Rosa, Alche Juan de Dios, Expósito Manuela, Brenes Manuel, Gandul Beatriz, Calleja Miguel Angel, Covas María-Isabel
Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía Oriental "Alejandro Otero" (FIBAO), Granada, Spain.
Instituto de Nutrición y Tecnología de Alimentos "José Mataix" (INyTA), Granada, Spain.
BMC Complement Altern Med. 2016 Oct 22;16(1):404. doi: 10.1186/s12906-016-1376-6.
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.
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.
The Trial has been registered in ClinicalTrials.gov ID: NCT02520739 .
初榨橄榄油是一种公认的健康食品，但不能大量食用。我们旨在评估对于人类而言，一种酚类含量高的优化初榨橄榄油（高酚初榨橄榄油，429毫克/千克）和一种功能性初榨橄榄油（功能型初榨橄榄油），这两种橄榄油均富含酚类化合物（429毫克/千克）和三萜酸（389毫克/千克），是否能带来超出标准初榨橄榄油（VOO）的健康益处。
方法/设计：将进行一项随机、双盲、交叉、对照研究。健康志愿者（年龄20至50岁）将被随机分为三组，每组每日食用生橄榄油：VOO组、高酚初榨橄榄油组和功能型初榨橄榄油组（30毫升/天）。橄榄油将在为期3周的时间段内给药，给药前有2周的洗脱期。主要结局指标将是脂质和DNA氧化、炎症及血管损伤的标志物。一项生物利用度和剂量反应研究将嵌套在这项持续食用研究中。该研究将由18名志愿者组成，并在单次服用每种橄榄油后的两个阶段进行。在基线以及服用橄榄油单剂量后4小时和6小时评估内皮功能和一氧化氮水平。
NUTRAOLEUM研究将首次提供关于橄榄油三萜类化合物（齐墩果酸和山楂酸）对人体的体内健康益处及其生物利用度和代谢情况的一级证据。
该试验已在ClinicalTrials.gov注册，注册号：NCT02520739 。
