Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

Metabolic Syndrome Clinical Trial

Official title:

Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03584581
• Other study ID #: PI2016/13 nº 77
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2018
• Source: Miguel Hernández University
• Contact: Ernesto Cortés-Castell, PhD
• Phone: +34966658500
• Email: ernesto.cortes[@]umh.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholesterol; Metabolic Disorder
• Metabolic Diseases
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• 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.
• Control
Placebo

Locations

Country	Name	City	State
Spain	General University Hospital of Elda	Elda	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Miguel Hernández University

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

Cortés Castell E, Veciana Galindo C, Torro Montell L, Sirvent Segura E, Rizo Baeza MM, Gil Guillén 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. — View Citation

Cortés Castell E, Veciana Galindo C, Torro Montell L, Sirvent Segura E, Rizo Baeza MM, Gil Guillén 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. — View Citation

Covas MI, Fitó M, Lamuela-Raventós RM, Sebastiá 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

Veciana Galindo C, Cortés Castell E, Torro Montell L, Sirvent Segura E, Rizo Baeza MM, Gil Guillén 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. — View Citation

Veciana-Galindo C, Cortés-Castell E, Torró-Montell L, Palazón-Bru A, Sirvent-Segura E, Rizo-Baeza MM, Gil-Guillén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholesterols levels	TC, HDL-C, LDL-C and TG.	1 month
Secondary	BMI (kg/m2)	Weight and height will be combined to report BMI in kg/m^2	1 month
Secondary	Blood pressure	SBP and DBP.	1 month
Secondary	Waist circumference (cm)		1 month