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临床试验/NCT04997122
NCT04997122已完成不适用

Assessment of the Health Effects of Olive Pomace Oil in Healthy and at Risk Consumers

Instituto de Ciencia y Tecnología de Alimentos y Nutrición2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Blood lipids

研究概览

简要总结

Healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either olive pomace oil (OPO) or high oleic acid sunflower oil (HOSO) as the only dietary fat in a randomized, crossover trial. The effects on blood lipids, glucose homeostasis, endothelial function, inflammatory cytokines, oxidative stress biomarkers and anthropometry were measured.

详细描述

This is the first study on the potential health effects of consumption of olive pomace oil.

After a 3-weeks run-in, 34 healthy and 30 hypercholesterolemic subjects were randomized to consume either OPO or HOSO (45 g/d) during 4 weeks, followed by a 3-week wash-out during which volunteers consumed the same amount of normal sunflower oil. During all the study, other dietary sources of fat (oil, nuts, butter, etc.) were restricted. Food intake was monitored by 3-d food records in each intervention stage and volunteers were instructed to maintain their normal physical and dietary habits (except for the changes in the consumption of other oils and fats).

At the beginning and end of each intervention stage, blood and urine samples were obtained, and blood pressure and anthropometric measurements were performed. A complete batch of analysis were performed, including serum lipids, endothelial function (flow mediated dilation (FMD), endothelial nitric oxide synthase (eNOS), vascular (VCAM-1) and intercellular (ICAM-1) cell adhesion molecules, E- and P-selectins), inflammatory and anti-inflammatory cytokines, glucose homeostasis/insulin resistance, antioxidant status and biomarkers of lipid oxidation (malondialdehyde (MDA), LDLox, ferric reducing antioxidant power (FRAP), oxygen radical absorbance capacity (ORAC), ABTS (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) quenching capacity) and anthropometry, along with determination of incretins, adipokines, and other clinical and hematological parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Oils were provided in unlabelled bottles (only differed in the colors of stoppers)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers (Total cholesterol < 200 mg/dL; LDL-cholesterol < 135 mg/dL)
  • Hypercholesterolemic volunteers (Total cholesterol 200-300 mg/dL; LDL-cholesterol 135-175 mg/dL)

排除标准

  • BMI > 30 Kg/m2
  • Vegetarians
  • Pregnant women
  • Medication/consumption of vitamins, dietary supplements
  • On antibiotic treatment 3 months before starting the study
  • Digestive disorders/pathologies (gastric ulcer, Chron's disease, inflammatory bowel syndrome, etc.)
  • Food allergies/intolerances

结局指标

主要结局

Blood lipids

时间窗: 4 weeks

Changes on total or LDL-cholesterol levels or triglycerides in at risk (hypercholesterolemic) subjects. No effect on blood lipids expected in healthy (normocholesterolemic ) volunteers

次要结局

  • Blood pressure(4 weeks)
  • Oxidative status(4 weeks)
  • Endothelial function(4 weeks)
  • Glucose homeostasis(4 weeks)
  • Inflammation(4 weeks)

研究者

发起方
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Raquel Mateos

Principal Investigator

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

研究点 (2)

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