Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

NCT03584581 | Unknown Phase 2

• 1 other identifier: PI2016/13 nº 77
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholesterol; Metabolic Disorder; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Cholesterols levels

  TC, HDL-C, LDL-C and TG.

  1 month

Secondary Outcomes (3)

• BMI (kg/m2)

  1 month

• Blood pressure

  1 month

• Waist circumference (cm)

  1 month

Study Arms (2)

Olive polyphenols

EXPERIMENTAL

Dietary Supplement: Olive polyphenols

Control

PLACEBO COMPARATOR

Dietary Supplement: Control

Interventions

Olive polyphenols 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.

Olive polyphenols

Control DIETARY_SUPPLEMENT

Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

General University Hospital of Elda

Elda, Alicante, 03690, Spain

RECRUITING

Related Publications (10)

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

  PMID: 23512608 BACKGROUND

• 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.

  PMID: 17023716 BACKGROUND

• 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.

  PMID: 15640490 BACKGROUND

• 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.

  PMID: 19099401 BACKGROUND

• 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.

  PMID: 11314237 BACKGROUND

• 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.

  PMID: 24972479 BACKGROUND

• 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.

  PMID: 25137269 BACKGROUND

• 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.

  PMID: 26040391 BACKGROUND

• 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.

  PMID: 25208788 BACKGROUND

• 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.

  PMID: 18729245 BACKGROUND

MeSH Terms

Conditions

Metabolic Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Central Study Contacts

Ernesto Cortés-Castell, PhD

CONTACT

+34966658500; ernesto.cortes@umh.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 12, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)