Clinical trial NCT03584581: Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols
Official title: Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cholesterol; Metabolic Disorder
Metabolic Syndrome
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cholesterols levels
timeFrame: 1 month
Secondary outcomes:
measure: BMI (kg/m2)
timeFrame: 1 month
measure: Blood pressure
timeFrame: 1 month
measure: Waist circumference (cm)
timeFrame: 1 month
Other outcomes:
Locations:
city: Elda
country: Spain
facility: General University Hospital of Elda
state: Alicante
Study officials:
References:
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citation: 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.
citation: 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.
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