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

NCT02520739 | Unknown Phase 3 DMC

• 1 other identifier: 13/11-C38
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

olive oil; phenolic compounds; triterpenes; oxidation and inflammation

Outcome Measures

Primary Outcomes (10)

• Systolic and diastolic blood pressures

  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.

  Up to 10 months

• Physical activity

  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

  Up to 10 months

• Serum glucose

  determined by enzymatic methods

  Up to 10 months

• Total cholesterol

  determined by enzymatic methods

  Up to 10 months

• high-density lipoprotein cholesterol

  determined by enzymatic methods

  Up to 10 months

• triglycerides

  determined by enzymatic methods

  Up to 10 months

• LDL cholesterol

  calculated by the Friedewald formula

  Up to 10 months

• Oxidized LDL (oxLDL)

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

  Up to 10 months

• Conjugated dienes in LDL

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

  Up to 10 months

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

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

  Up to 10 months

Secondary Outcomes (1)

• Endothelial Function

  Up to 10 months

Study Arms (3)

Virgin Olive Oil

PLACEBO COMPARATOR

Virgin olive oil obtained by traditional procedures (VOO);

Dietary Supplement: Virgin Olive Oil (VOO)

Optimized High Phenolic Content Oil

EXPERIMENTAL

Optimized virgin olive oil with a high phenolic content (OHPCO);

Dietary Supplement: Optimized High Phenolic Content Oil (OHPCO)

Functional Olive Oil

EXPERIMENTAL

Functional olive oil (FOO) with both high phenolic compounds and triterpene content.

Dietary Supplement: Functional Olive Oil (FOO)

Interventions

Virgin Olive Oil (VOO) DIETARY_SUPPLEMENT

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.

Virgin Olive Oil

Optimized High Phenolic Content Oil (OHPCO) DIETARY_SUPPLEMENT

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.

Optimized High Phenolic Content Oil

Functional Olive Oil (FOO) DIETARY_SUPPLEMENT

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.

Functional Olive Oil

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: lead
• Hospital del Mar: collaborator
• Instituto de Nutrición y Tecnología de los Alimentos: collaborator

Study Sites (1)

University Hospital Virgen de las Nieves

Granada, Granada, 18012, Spain

Location

Related Publications (3)

• Sanchez-Rodriguez E, Biel-Glesson S, Fernandez-Navarro JR, Calleja MA, Espejo-Calvo JA, Gil-Extremera B, de la Torre R, Fito M, Covas MI, Vilchez P, Alche JD, Martinez de Victoria E, Gil A, Mesa MD. Effects of Virgin Olive Oils Differing in Their Bioactive Compound Contents on Biomarkers of Oxidative Stress and Inflammation in Healthy Adults: A Randomized Double-Blind Controlled Trial. Nutrients. 2019 Mar 6;11(3):561. doi: 10.3390/nu11030561.

  PMID: 30845690 DERIVED

• Sanchez-Rodriguez E, Lima-Cabello E, Biel-Glesson S, Fernandez-Navarro JR, Calleja MA, Roca M, Espejo-Calvo JA, Gil-Extremera B, Soria-Florido M, de la Torre R, Fito M, Covas MI, Alche JD, Martinez de Victoria E, Gil A, Mesa MD. Effects of Virgin Olive Oils Differing in Their Bioactive Compound Contents on Metabolic Syndrome and Endothelial Functional Risk Biomarkers in Healthy Adults: A Randomized Double-Blind Controlled Trial. Nutrients. 2018 May 16;10(5):626. doi: 10.3390/nu10050626.

  PMID: 29772657 DERIVED

• Biel S, Mesa MD, de la Torre R, Espejo JA, Fernandez-Navarro JR, Fito M, Sanchez-Rodriguez E, Rosa C, Marchal R, Alche JD, Exposito M, Brenes M, Gandul B, Calleja MA, Covas MI. The NUTRAOLEOUM Study, a randomized controlled trial, for achieving nutritional added value for olive oils. BMC Complement Altern Med. 2016 Oct 22;16(1):404. doi: 10.1186/s12906-016-1376-6.

  PMID: 27770787 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• BLAS GIL, Doctor

  Medical doctor

  PRINCIPAL INVESTIGATOR

• Montse Fito, Doctor

  Head of Research Group

  PRINCIPAL INVESTIGATOR

• Emilo Martínez

  Head of Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF PROJECT MANAGEMENT

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: August 13, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

ES (1)