Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

Phase 2

• Conditions: Cholesterol; Metabolic Disorder; Metabolic Syndrome
• Interventions: Dietary Supplement: Olive polyphenols; Dietary Supplement: Control

• Registration Number: NCT03584581
• Lead Sponsor: Universidad Miguel Hernandez de Elche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-06-27
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-11
• Last Update Submitted: 2018-07-11
• Study First Posted: 2018-07-12
• Last Update Posted: 2018-07-12
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olive polyphenols	Olive polyphenols	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Cholesterols levels	1 month	TC, HDL-C, LDL-C and TG.

Secondary Outcome Measures

Name	Time	Method
BMI (kg/m2)	1 month	Weight and height will be combined to report BMI in kg/m\^2
Blood pressure	1 month	SBP and DBP.
Waist circumference (cm)	1 month

Trial Locations

Locations (1)

General University Hospital of Elda; 🇪🇸 Elda, Alicante, Spain