Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

NCT ID: NCT03584581

Last Updated: 2018-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-12-31

Brief Summary

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This study is designed to determine whether a standardized intervention in the health center and based on hygienic dietary measures and physical exercise, supplemented with a polyphenol extract in patients, achieves a greater benefit in the reduction of LDL cholesterol in dyslipidemias in the short term.

Detailed Description

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Conditions

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Cholesterol; Metabolic Disorder Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Olive polyphenols

Group Type EXPERIMENTAL

Olive polyphenols

Intervention Type DIETARY_SUPPLEMENT

The amount of polyphenols to be supplied is within the ranges of absolute biosecurity food described by different authors and used in different studies.

Control

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Olive polyphenols

The amount of polyphenols to be supplied is within the ranges of absolute biosecurity food described by different authors and used in different studies.

Intervention Type DIETARY_SUPPLEMENT

Control

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with dyslipidemia without the need for pharmacological treatment, but with annual follow-up of their dyslipidemia and with baseline LDL-cholesterol values.
* Patients to whom the annual analysis will be carried out for control of the lipid profile and who agree to postpone it during the month of the health education study.
* Patients who undergo hygienic-dietetic intervention and exercise.
* Patients willing to ingest the nutritional supplement of polyphenols that will be supplied to them.
* Signed the informed consent.

Exclusion Criteria

* \<18 years old.
* High cardiovascular risk.
* With pharmacological treatment.
* With some previous chronic disease.
* With some allergy to the compounds of the product and placebo according to the technical specifications.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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Ernesto Cortés-Castell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General University Hospital of Elda

Elda, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ernesto Cortés-Castell, PhD

Role: CONTACT

+34966658500

Facility Contacts

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Vicente F Gil-Guillén, MD, PhD

Role: primary

+34966975017

References

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Tangney CC, Rasmussen HE. Polyphenols, inflammation, and cardiovascular disease. Curr Atheroscler Rep. 2013 May;15(5):324. doi: 10.1007/s11883-013-0324-x.

Reference Type BACKGROUND
PMID: 23512608 (View on PubMed)

Bleys J, Miller ER 3rd, Pastor-Barriuso R, Appel LJ, Guallar E. Vitamin-mineral supplementation and the progression of atherosclerosis: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2006 Oct;84(4):880-7; quiz 954-5. doi: 10.1093/ajcn/84.4.880.

Reference Type BACKGROUND
PMID: 17023716 (View on PubMed)

Halliwell B, Rafter J, Jenner A. Health promotion by flavonoids, tocopherols, tocotrienols, and other phenols: direct or indirect effects? Antioxidant or not? Am J Clin Nutr. 2005 Jan;81(1 Suppl):268S-276S. doi: 10.1093/ajcn/81.1.268S.

Reference Type BACKGROUND
PMID: 15640490 (View on PubMed)

Obied HK, Prenzler PD, Konczak I, Rehman AU, Robards K. Chemistry and bioactivity of olive biophenols in some antioxidant and antiproliferative in vitro bioassays. Chem Res Toxicol. 2009 Jan;22(1):227-34. doi: 10.1021/tx8004168.

Reference Type BACKGROUND
PMID: 19099401 (View on PubMed)

Covas MI, Fito M, Lamuela-Raventos RM, Sebastia N, de la Torre-Boronat C, Marrugat J. Virgin olive oil phenolic compounds: binding to human low density lipoprotein (LDL) and effect on LDL oxidation. Int J Clin Pharmacol Res. 2000;20(3-4):49-54.

Reference Type BACKGROUND
PMID: 11314237 (View on PubMed)

Veciana Galindo C, Cortes Castell E, Torro Montell L, Sirvent Segura E, Rizo Baeza MM, Gil Guillen V. [Assessment of cytotoxicity and biosafety of polyphenolic extracts from olive pits]. Nutr Hosp. 2014 Jun 1;29(6):1388-93. doi: 10.3305/nh.2014.29.6.7141. Spanish.

Reference Type BACKGROUND
PMID: 24972479 (View on PubMed)

Cortes Castell E, Veciana Galindo C, Torro Montell L, Sirvent Segura E, Rizo Baeza MM, Gil Guillen V. [Anti-inflammatory activity of olive seed polyphenolic extract in the THP1-XBLUE-CD14 human monocytes cell line]. Nutr Hosp. 2014 Jul 1;30(1):113-7. doi: 10.3305/nh.2014.30.1.7482. Spanish.

Reference Type BACKGROUND
PMID: 25137269 (View on PubMed)

Veciana-Galindo C, Cortes-Castell E, Torro-Montell L, Palazon-Bru A, Sirvent-Segura E, Rizo-Baeza MM, Gil-Guillen VF. Anti-adipogenic activity of an olive seed extract in mouse fibroblasts. Nutr Hosp. 2015 Jun 1;31(6):2747-51. doi: 10.3305/nh.2015.31.6.8997.

Reference Type BACKGROUND
PMID: 26040391 (View on PubMed)

Cortes Castell E, Veciana Galindo C, Torro Montell L, Sirvent Segura E, Rizo Baeza MM, Gil Guillen V. [Effect on zebrafish neurodevelopment and neuroprotection of a polyphenolic extract olive seeds]. Nutr Hosp. 2014 Aug 1;30(2):338-42. doi: 10.3305/nh.2014.30.2.7604. Spanish.

Reference Type BACKGROUND
PMID: 25208788 (View on PubMed)

Perrinjaquet-Moccetti T, Busjahn A, Schmidlin C, Schmidt A, Bradl B, Aydogan C. Food supplementation with an olive (Olea europaea L.) leaf extract reduces blood pressure in borderline hypertensive monozygotic twins. Phytother Res. 2008 Sep;22(9):1239-42. doi: 10.1002/ptr.2455.

Reference Type BACKGROUND
PMID: 18729245 (View on PubMed)

Other Identifiers

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PI2016/13 nº 77

Identifier Type: -

Identifier Source: org_study_id

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