Back to resultsEffects on Lipid Metabolism of Olive Extracts Rich in Polyphenols
Primary Purpose
Cholesterol; Metabolic Disorder, Metabolic Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Olive polyphenols
Control
Sponsored by
About this trial
This is an interventional treatment trial for Cholesterol; Metabolic Disorder
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.
Sites / Locations
- General University Hospital of EldaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Olive polyphenols
Control
Arm Description
Outcomes
Primary Outcome Measures
Cholesterols levels
TC, HDL-C, LDL-C and TG.
Secondary Outcome Measures
BMI (kg/m2)
Weight and height will be combined to report BMI in kg/m^2
Blood pressure
SBP and DBP.
Waist circumference (cm)
Full Information
NCT ID
NCT03584581
First Posted
June 27, 2018
Last Updated
July 11, 2018
Sponsor
Universidad Miguel Hernandez de Elche
1. Study Identification
Unique Protocol Identification Number
NCT03584581
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholesterol; Metabolic Disorder, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Olive polyphenols
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive polyphenols
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Cholesterols levels
Description
TC, HDL-C, LDL-C and TG.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
BMI (kg/m2)
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
1 month
Title
Blood pressure
Description
SBP and DBP.
Time Frame
1 month
Title
Waist circumference (cm)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ernesto Cortés-Castell, PhD
Phone
+34966658500
Email
ernesto.cortes@umh.es
Facility Information:
Facility Name
General University Hospital of Elda
City
Elda
State/Province
Alicante
ZIP/Postal Code
03690
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente F Gil-Guillén, MD, PhD
Phone
+34966975017
Email
vte.gil@gmail.com
First Name & Middle Initial & Last Name & Degree
Ernesto Cortés-Castell, PhD
First Name & Middle Initial & Last Name & Degree
Antonio Palazón-Bru, PhD
First Name & Middle Initial & Last Name & Degree
María M Rizo-Baeza, PhD
First Name & Middle Initial & Last Name & Degree
Vicente F Gil-Guillén, MD, PhD
First Name & Middle Initial & Last Name & Degree
Luís Torró-Montell, MPharm
First Name & Middle Initial & Last Name & Degree
Enrique Hermida-Campa, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will not be publicly available.
Citations:
PubMed Identifier
23512608
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.
Results Reference
background
PubMed Identifier
17023716
Citation
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.
Results Reference
background
PubMed Identifier
15640490
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.
Results Reference
background
PubMed Identifier
19099401
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.
Results Reference
background
PubMed Identifier
11314237
Citation
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.
Results Reference
background
PubMed Identifier
24972479
Citation
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.
Results Reference
background
PubMed Identifier
25137269
Citation
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.
Results Reference
background
PubMed Identifier
26040391
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.
Results Reference
background
PubMed Identifier
25208788
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.
Results Reference
background
PubMed Identifier
18729245
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.
Results Reference
background
Learn more about this trial
Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols
We'll reach out to this number within 24 hrs