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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olive polyphenols | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterols levels | TC, HDL-C, LDL-C and TG. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| BMI (kg/m2) | Weight and height will be combined to report BMI in kg/m^2 | 1 month |
| Blood pressure | SBP and DBP. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ernesto Cortés-Castell, PhD | Contact | +34966658500 | ernesto.cortes@umh.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital of Elda | Recruiting | Elda | Alicante | 03690 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23512608 | Background | Tangney CC, Rasmussen HE. Polyphenols, inflammation, and cardiovascular disease. Curr Atheroscler Rep. 2013 May;15(5):324. doi: 10.1007/s11883-013-0324-x. | |
| 17023716 | 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. |
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The data will not be publicly available.
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| Control | Dietary Supplement | Placebo |
|
| Waist circumference (cm) | 1 month |
| 15640490 | 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. |
| 19099401 | 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. |
| 11314237 | 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. |
| 24972479 | 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. |
| 25137269 | 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. |
| 26040391 | 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. |
| 25208788 | 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. |
| 18729245 | 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. |