Mediterranean Diet and Endothelial Function

Cardiovascular Diseases Clinical Trial

Official title:

Mediterranean Diet and Endothelial Function in Obese and Overweight Patients: the Role of Olive Oil, Non Fried Fish and Nuts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797211
• Other study ID #: 01
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2013
• Last updated: February 20, 2013
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: February 2013
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To assess the effect of Mediterranean diet and some of its specific components (olive oil, non fried fish and nuts) on endothelial function in overweight and obese patients

Description:

Abdominal obesity is well known to increase the risk of cardiovascular disease (CVD), since it is commonly associated with hypertension, dyslipidemia, impaired fasting glucose, type 2 diabetes, metabolic syndrome, insulin resistance, systemic inflammation and endothelium dysfunction.

Abnormal endothelial function, expressed as lower vasodilatation through flow-mediated vasodilatation (FMD) of brachial artery in response to an increase in blood flow, is considered an index of subclinical atherosclerosis, and an early hallmark of cardiovascular disease, with a strong prognostic value for future cardiovascular events. Changes in diet, level of physical activity and behavior are well known key elements influence endothelial function. Recent studies seem to show that Mediterranean diet has beneficial role on cardiovascular risk. It could protect against the development of coronary heart disease also through a possible effect on body weight and obesity.

At the best of our knowledge, the effect of Mediterranean diet on endothelial function in obese subjects has not been definitely established. Therefore, the aim of this study was to evaluate the impact of Mediterranean diet on anthropometric parameters (body weight, BMI and waist circumference), lipid profile [total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C)], triglycerides (TG), fasting glucose and endothelium function, evaluated by FMD, in a group of obese and overweight subjects. In particular, subjects were invited to follow a standard Mediterranean diet for a short (3 months) or a longer (18 months) period. The specific role of some components of Mediterranean diet (olive oil or non fried fish or nuts) was also investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

BMI: > 25.0 kg/m2 Age between 18-70 years

Exclusion Criteria:

BMI < 25.0 kg/m2 Age <18 or >70 years low left ventricular ejection fraction (LVEF < 50%) symptomatic cardiac disease in advanced stage or poorly controlled by medication cerebral disorders major liver and kidney diseases cancer excessive alcohol intake use of drugs addressed to lose weight.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Mediterranean diet
Patients underwent administration of Mediterranean diet and olive oil, or Mediterranean diet and not-fried fish, or Mediterranean diet and nuts.

Locations

Country	Name	City	State
Italy	Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, University of Bari	Bari

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

References & Publications (23)

Anderson JS, Nettleton JA, Herrington DM, Johnson WC, Tsai MY, Siscovick D. Relation of omega-3 fatty acid and dietary fish intake with brachial artery flow-mediated vasodilation in the Multi-Ethnic Study of Atherosclerosis. Am J Clin Nutr. 2010 Nov;92(5) — View Citation

Babio N, Bulló M, Basora J, Martínez-González MA, Fernández-Ballart J, Márquez-Sandoval F, Molina C, Salas-Salvadó J; Nureta-PREDIMED Investigators. Adherence to the Mediterranean diet and risk of metabolic syndrome and its components. Nutr Metab Cardiova — View Citation

de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16; — View Citation

Félétou M, Vanhoutte PM. Endothelium-derived hyperpolarizing factor: where are we now? Arterioscler Thromb Vasc Biol. 2006 Jun;26(6):1215-25. Epub 2006 Mar 16. Review. — View Citation

Hamdy O. Lifestyle modification and endothelial function in obese subjects. Expert Rev Cardiovasc Ther. 2005 Mar;3(2):231-41. Review. — View Citation

Hotchkiss JW, Leyland AH. The relationship between body size and mortality in the linked Scottish Health Surveys: cross-sectional surveys with follow-up. Int J Obes (Lond). 2011 Jun;35(6):838-51. doi: 10.1038/ijo.2010.207. Epub 2010 Oct 5. — View Citation

Issa C, Darmon N, Salameh P, Maillot M, Batal M, Lairon D. A Mediterranean diet pattern with low consumption of liquid sweets and refined cereals is negatively associated with adiposity in adults from rural Lebanon. Int J Obes (Lond). 2011 Feb;35(2):251-8 — View Citation

Jambrik Z, Venneri L, Varga A, Rigo F, Borges A, Picano E. Peripheral vascular endothelial function testing for the diagnosis of coronary artery disease. Am Heart J. 2004 Oct;148(4):684-9. — View Citation

Kastorini CM, Milionis HJ, Goudevenos JA, Panagiotakos DB. Mediterranean diet and coronary heart disease: is obesity a link? - A systematic review. Nutr Metab Cardiovasc Dis. 2010 Sep;20(7):536-51. doi: 10.1016/j.numecd.2010.04.006. Review. — View Citation

Kelly JH Jr, Sabaté J. Nuts and coronary heart disease: an epidemiological perspective. Br J Nutr. 2006 Nov;96 Suppl 2:S61-7. Review. Erratum in: Br J Nutr. 2008 Feb;99(2):447-8. — View Citation

Levitan EB, Wolk A, Mittleman MA. Fish consumption, marine omega-3 fatty acids, and incidence of heart failure: a population-based prospective study of middle-aged and elderly men. Eur Heart J. 2009 Jun;30(12):1495-500. doi: 10.1093/eurheartj/ehp111. Epub — View Citation

Massaro M, Basta G, Lazzerini G, Carluccio MA, Bosetti F, Solaini G, Visioli F, Paolicchi A, De Caterina R. Quenching of intracellular ROS generation as a mechanism for oleate-induced reduction of endothelial activation and early atherogenesis. Thromb Hae — View Citation

Perona JS, Cabello-Moruno R, Ruiz-Gutierrez V. The role of virgin olive oil components in the modulation of endothelial function. J Nutr Biochem. 2006 Jul;17(7):429-45. Epub 2005 Dec 12. Review. — View Citation

Robertson RM, Smaha L. Can a Mediterranean-style diet reduce heart disease? Circulation. 2001 Apr 3;103(13):1821-2. — View Citation

Romaguera D, Norat T, Vergnaud AC, Mouw T, May AM, Agudo A, Buckland G, Slimani N, Rinaldi S, Couto E, Clavel-Chapelon F, Boutron-Ruault MC, Cottet V, Rohrmann S, Teucher B, Bergmann M, Boeing H, Tjønneland A, Halkjaer J, Jakobsen MU, Dahm CC, Travier N, — View Citation

Sabaté J, Ang Y. Nuts and health outcomes: new epidemiologic evidence. Am J Clin Nutr. 2009 May;89(5):1643S-1648S. doi: 10.3945/ajcn.2009.26736Q. Epub 2009 Mar 25. Review. — View Citation

Serdula MK, Mokdad AH, Williamson DF, Galuska DA, Mendlein JM, Heath GW. Prevalence of attempting weight loss and strategies for controlling weight. JAMA. 1999 Oct 13;282(14):1353-8. — View Citation

Shah AP, Ichiuji AM, Han JK, Traina M, El-Bialy A, Meymandi SK, Wachsner RY. Cardiovascular and endothelial effects of fish oil supplementation in healthy volunteers. J Cardiovasc Pharmacol Ther. 2007 Sep;12(3):213-9. — View Citation

Tuck KL, Hayball PJ. Major phenolic compounds in olive oil: metabolism and health effects. J Nutr Biochem. 2002 Nov;13(11):636-644. — View Citation

Urpi-Sarda M, Casas R, Chiva-Blanch G, Romero-Mamani ES, Valderas-Martínez P, Arranz S, Andres-Lacueva C, Llorach R, Medina-Remón A, Lamuela-Raventos RM, Estruch R. Virgin olive oil and nuts as key foods of the Mediterranean diet effects on inflammatory b — View Citation

von Ruesten A, Steffen A, Floegel A, van der A DL, Masala G, Tjønneland A, Halkjaer J, Palli D, Wareham NJ, Loos RJ, Sørensen TI, Boeing H. Trend in obesity prevalence in European adult cohort populations during follow-up since 1996 and their predictions — View Citation

Wildman RP, Muntner P, Reynolds K, McGinn AP, Rajpathak S, Wylie-Rosett J, Sowers MR. The obese without cardiometabolic risk factor clustering and the normal weight with cardiometabolic risk factor clustering: prevalence and correlates of 2 phenotypes amo — View Citation

Yoshida T, Kawano H, Miyamoto S, Motoyama T, Fukushima H, Hirai N, Ogawa H. Prognostic value of flow-mediated dilation of the brachial artery in patients with cardiovascular disease. Intern Med. 2006;45(9):575-9. Epub 2006 Jun 1. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 months outcome (composite outcome)	Anthropometric parameters (BMI, waist circumference [WC] and weight) a significant decrease, while FMD ones showed a significant increase after 3 months of Mediterranean diet as compared to baseline levels. The addition per se of olive oil or non fried fish or nuts to the standard Mediterranean diet did not influence anthropometric parameters, since BMI, WC and body weight of groups A, B and C were not significant different from those of the control group. After 3 months, FMD was not higher wether olive oil or non fried fish or nuts were added to standard Mediterranean diet.	3 months after enrollment	No
Secondary	18 months follow-up evaluations (composite outcome)	After 18 months of dietary treatment, we observed a significant increase of HDL-C, a decrease of TC and LDL-C, no differences in TG plasma concentrations and fasting glucose. The addition per se of olive oil or non fried fish or nuts to the standard Mediterranean diet did not influence the lipid profile. Anthropometric parameters showed a significant decrease and FMD showed a significant increase after 18 months, as compared to 3 months levels. Olive oil, non fried fish or nuts to the standard Mediterranean diet did not influence anthropometric parameters, since BMI, WC and body weight of groups A, B and C were not significant different from those of the control group. It is noteworthy that, after 18 months of Mediterranean diet, but not after 3 months, FMD was higher wether olive oil or non fried fish or nuts were added to standard Mediterranean diet. Lastly, at 18 months, the FMD levels of groups A, B, and C were significantly higher than those of control group.	18 months after enrollment period	No