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临床试验/NCT02520739
NCT02520739Unknown3 期

New Industrial Procedures for Achieving a Nutritional Added Value of the Olive Oil. The NUTRAOLEUM Study

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
57
试验地点
2
主要终点
Systolic and diastolic blood pressures

研究概览

简要总结

The Mediterranean diet, in which olive oil is the main source of fat, has shown to be protective for chronic degenerative diseases. These diseases, such as cardiovascular, cancer, and neurodegenerative, and even the aging process, are linked to oxidative stress and inflammation. Recently, the Prevention through Mediterranean Diet Study has provided for first time evidence of the benefits of the Mediterranean diet on the primary prevention of cardiovascular disease.

Olive oil, besides its high content of a healthy fat, the monounsaturated (MUFA) one: the oleic acid, has minor components with bioactive properties. The minor components of virgin olive oil are classified into two types: the unsaponifiable fraction, defined as the fraction extracted with solvents after the saponification of the oil, and the soluble fraction which includes the phenolic compounds. The content of the phenolic compounds (polyphenols) of an olive oil depends of the variety of the olive fruit, the cultivar, the climate, the ripeness of the olive, and the type of processing. Virgin olive oils obtained from the first press of centrifugation of the olives are those with high phenolic content. On November 2011, the European Food Safety Authority released a claim concerning the benefits of the daily ingestion of olive oil rich in phenolic compounds, such as the virgin olive oil. Due to this, the need to optimize the olive oil processing in order to obtain high phenolic content olive oils is one of the current goals in terms of increasing the nutritional value of an olive oil. To obtain an optimized olive oil with high phenolic content (OHPCO) has been one of the achievements within the frame of the NUTRAOLEOUM Project.

However, the healthy properties of the new olive oils (OHPCO and FOO), according to the Evidence Based Medicine must be tested in proper clinical randomized trials. New olive oil products need to be tested in front of the parental ones (i.e. virgin olive oil obtained by common procedures) in order to ensure that their healthy properties are highlighted. This is the purpose of the NUTRAOLEUM Study. In order to be able to obtain future health claims from EFSA or FDA, for the products, the investigators will also examine the bioavailability in humans of the active principles (phenolic compounds and triterpenes) of the olive oils, as well as possible basic mechanisms involved in the potential health benefits of the olive oils tested.

详细描述

The Mediterranean diet, in which olive oil is the main source of fat, has shown to be protective for chronic degenerative diseases. These diseases, such as cardiovascular, cancer, and neurodegenerative, and even the aging process, are linked to oxidative stress and inflammation. Recently, the Prevention through Mediterranean Diet Study has provided for first time evidence of the benefits of the Mediterranean diet on the primary prevention of cardiovascular disease. In human, randomized, controlled studies olive oil, and particularly the virgin one rich in phenolic compounds, have been shown to provide benefits on oxidative damage, inflammation, and on the generation of cell adhesion molecules, a key process for atherosclerosis development.

Olive oil, besides its high content of a healthy fat, the monounsaturated (MUFA) one: the oleic acid, has minor components with bioactive properties. The minor components of virgin olive oil are classified into two types: the unsaponifiable fraction, defined as the fraction extracted with solvents after the saponification of the oil, and the soluble fraction which includes the phenolic compounds. The content of the phenolic compounds (polyphenols) of an olive oil depends of the variety of the olive fruit, the cultivar, the climate, the ripeness of the olive, and the type of processing. Virgin olive oils obtained from the first press of centrifugation of the olives are those with high phenolic content. On November 2011, the European Food Safety Authority (EFSA, 2011) released a claim concerning the benefits of the daily ingestion of olive oil rich in phenolic compounds, such as the virgin olive oil. The Panel considers that in order to bear the claim, 5 mg of hydroxytyrosol and its derivatives (e.g. oleuropein complex and tyrosol) in olive oil should be consumed daily. These quantities, if provided by moderate amounts of olive oil, can be easily consumed in the context of a balanced diet (EFSA, 2011). The conditions for the use of the claim in the bottles, are regulated in the Commission Regulation (EU).Nº 432/2012 of 16 May 2012 (Official Journal of the European Union , L136/1. 25, 5, 2012). According to this regulation: "The claim may be used only for olive oil which contains at least 5 mg of hydroxytyrosol and its derivatives (e.g. oleuropein complex and tyrosol) per 20 g of olive oil. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 20 g of olive oil". This implies that only high phenolic content olive oils can bear the claim. Due to this, the need to optimize the olive oil processing in order to obtain high phenolic content olive oils is one of the current goals in terms of increasing the nutritional value of an olive oil. To obtain an optimized olive oil with high phenolic content (OHPCO) has been one of the achievements within the frame of the NUTRAOLEOUM Project. In this sense we must point out that, among minor olive oil components, not only polyphenols, but components of the unsaponifiable fraction such as the triterpenes have also shown to have potential for providing benefits for health. The seeds and the skin of the olives, used to produce pomace olive oil, are very rich in triterpenes. Pomace olive oil and triterpenes, such as oleanolic and maslinic acids, have shown anti-inflammatory, antioxidant, and vasodilatation properties in cellular and animal models. Due to this, the enrichment of an OHPCO with olive triterpenes, by joining the healthy properties of virgin and pomace olive oil, will result in a Functional Olive Oil (FOO) with a high bioactive potential for health. This FOO has also been developed in the frame of the NUTRAOLEUM Project. Consumers are every day asking for an "added value" in the nutritional properties of the food to be purchased and responses from the Olive Oil Industry are needed.

However, the healthy properties of the new olive oils (OHPCO and FOO), according to the Evidence Based Medicine must be tested in proper clinical randomized trials. New olive oil products need to be tested in front of the parental ones (i.e. virgin olive oil obtained by common procedures) in order to ensure that their healthy properties are highlighted. This is the purpose of the NUTRAOLEUM Study. In order to be able to obtain future health claims from EFSA or FDA, for the products, we will also examine the bioavailability in humans of the active principles (phenolic compounds and triterpenes) of the olive oils, as well as possible basic mechanisms involved in the potential health benefits of the olive oils tested.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy on the basis of physical examination and routine biochemical and hematological laboratory determinations,
  • willingness to provide written, informed consent and
  • to agree to adherence to the protocol.

排除标准

  • intake of antioxidant supplements,
  • aspirin, or any other drug with established antioxidant properties,
  • hyperlipemia,
  • obesity (body mass index >30 kg/m2),
  • diabetes,
  • hypertension,
  • celiac or other intestinal disease,
  • any condition limiting mobility,
  • life-threatening diseases, or
  • any other disease or condition that would impair compliance.

结局指标

主要结局

Systolic and diastolic blood pressures

时间窗: Up to 10 months

measured with a mercury sphygmomanometer after a minimum of 10 minutes rest in the seated position; the average of two measurements was taken for analysis.

Serum glucose

时间窗: Up to 10 months

determined by enzymatic methods

Oxidized LDL (oxLDL)

时间窗: Up to 10 months

determined in plasma by ELISA using two antibodies against antigenic determinants of oxidized apolipoprotein B molecule (ox-LDL, Uppsala, Sweden)

Conjugated dienes in LDL

时间窗: Up to 10 months

measured spectrophotometrically at 234 nm and 300 nm after Cu++ oxidation

Physical activity

时间窗: Up to 10 months

a potential confounder variable concerning oxidative and anti-inflammatory status was recorded at the beginning and at the of the study, and assessed by the Minnesota Leisure Time Physical Activity Questionnaire validated for its use in Spanish men and women

Total cholesterol

时间窗: Up to 10 months

determined by enzymatic methods

high-density lipoprotein cholesterol

时间窗: Up to 10 months

determined by enzymatic methods

triglycerides

时间窗: Up to 10 months

determined by enzymatic methods

LDL cholesterol

时间窗: Up to 10 months

calculated by the Friedewald formula

Tyrosol and hydroxytyrosol in urine samples and oleanolic and maslinic in plasma

时间窗: Up to 10 months

measured as markers of compliance of the intervention, will be determined by gas chromatography-mass spectrometry

次要结局

  • Endothelial Function(Up to 10 months)

研究者

发起方
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Biel

HEAD OF PROJECT MANAGEMENT

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

研究点 (2)

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