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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02520739
Recruitment Status : Unknown
Verified March 2016 by Sarah Biel, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental.
Recruitment status was:  Active, not recruiting
First Posted : August 13, 2015
Last Update Posted : March 3, 2016
Sponsor:
Collaborators:
Hospital del Mar
Instituto de Nutrición y Tecnología de los Alimentos
Information provided by (Responsible Party):
Sarah Biel, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: Virgin Olive Oil (VOO) Dietary Supplement: Optimized High Phenolic Content Oil (OHPCO) Dietary Supplement: Functional Olive Oil (FOO) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: New Industrial Procedures for Achieving a Nutritional Added Value of the Olive Oil. The NUTRAOLEUM Study
Study Start Date : February 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
Placebo Comparator: Virgin Olive Oil
Virgin olive oil obtained by traditional procedures (VOO);
Dietary Supplement: Virgin Olive Oil (VOO)
VOO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of VOO distributed over 3 meals. Daily doses of VOO were blindly prepared in special containers, with the corresponding 30 mL VOO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed VOO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.

Experimental: Optimized High Phenolic Content Oil
Optimized virgin olive oil with a high phenolic content (OHPCO);
Dietary Supplement: Optimized High Phenolic Content Oil (OHPCO)
OHPCO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of OHPCO distributed over 3 meals. Daily doses of OHPCO were blindly prepared in special containers, with the corresponding 30 mL OHPCO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed OHPCO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.

Experimental: Functional Olive Oil
Functional olive oil (FOO) with both high phenolic compounds and triterpene content.
Dietary Supplement: Functional Olive Oil (FOO)
FOO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of FOO distributed over 3 meals. Daily doses of FOO were blindly prepared in special containers, with the corresponding 30 mL FOO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed FOO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.




Primary Outcome Measures :
  1. Systolic and diastolic blood pressures [ Time Frame: 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.

  2. Physical activity [ Time Frame: 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

  3. Serum glucose [ Time Frame: Up to 10 months ]
    determined by enzymatic methods

  4. Total cholesterol [ Time Frame: Up to 10 months ]
    determined by enzymatic methods

  5. high-density lipoprotein cholesterol [ Time Frame: Up to 10 months ]
    determined by enzymatic methods

  6. triglycerides [ Time Frame: Up to 10 months ]
    determined by enzymatic methods

  7. LDL cholesterol [ Time Frame: Up to 10 months ]
    calculated by the Friedewald formula

  8. Oxidized LDL (oxLDL) [ Time Frame: Up to 10 months ]
    determined in plasma by ELISA using two antibodies against antigenic determinants of oxidized apolipoprotein B molecule (ox-LDL, Uppsala, Sweden)

  9. Conjugated dienes in LDL [ Time Frame: Up to 10 months ]
    measured spectrophotometrically at 234 nm and 300 nm after Cu++ oxidation

  10. Tyrosol and hydroxytyrosol in urine samples and oleanolic and maslinic in plasma [ Time Frame: Up to 10 months ]
    measured as markers of compliance of the intervention, will be determined by gas chromatography-mass spectrometry


Secondary Outcome Measures :
  1. Endothelial Function [ Time Frame: Up to 10 months ]
    Endothelial function was measured at baseline (0h) and at 4 and 6h after each olive oil administration. Peripheral arterial tonometry signals were obtained using a device. Finger probes were placed on the middle finger of each subject's hand. These probes comprised a system of inflatable latex air cuffs connected by pneumatic tubes to an inflating device controlled through a computer algorithm. A constant counter pressure (pre-determined by baseline diastolic blood pressure) was applied. There was no occlusion of arterial blood flow. Pulsatile volume changes of the distal digit induced pressure alterations in the finger cuff, which were sensed by pressure transducers and transmitted to and recorded by the device. A decrease in the arterial blood volume in the distal finger tip caused a decrease in pulsatile arterial column changes, reflected as a decrease in the measured PAT signal.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • smoking,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520739


Locations
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Spain
University Hospital Virgen de las Nieves
Granada, Spain, 18012
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Hospital del Mar
Instituto de Nutrición y Tecnología de los Alimentos
Investigators
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Principal Investigator: BLAS GIL, Doctor Medical doctor
Principal Investigator: Montse Fito, Doctor Head of Research Group
Principal Investigator: Emilo Martínez Head of Research Group
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sarah Biel, HEAD OF PROJECT MANAGEMENT, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
ClinicalTrials.gov Identifier: NCT02520739    
Other Study ID Numbers: 13/11-C38
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Keywords provided by Sarah Biel, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental:
olive oil
phenolic compounds
triterpenes
oxidation and inflammation
Additional relevant MeSH terms:
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Cardiovascular Diseases