Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women

NCT01293344 | Completed

• 1 other identifier: ALIMED-2007-180 A3 R-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet in which all foods and drinks are provided to subjects. The investigators hypothesize that the decrease in LDL-cholesterol will be more important in men than in women.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular diseases; Controlled nutritional intervention; Sex differences; Women; Men; Cardiovascular risk; Lipid profile; Blood pressure; Insulin sensitivity; Inflammatory markers; Endothelial function; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Cardiometabolic outcomes

  Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoprotein (apo) B, apo A-1 and apo A-2 plasma concentrations, systolic and diastolic blood pressure, glucose and insulin concentrations during a 180-min oral glucose tolerance test, insulin sensitivity, CRP and Interleukine-6 levels, oxidized-LDL, E-selectin, ICAM-1 and VCAM-1.

  At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks).

Secondary Outcomes (5)

• Nutritional variables

  At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks).

• Eating behaviors

  At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)

• Appetite ratings

  At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)

• physical activity habits

  At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks)

• Anthropometric measurements

  At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks)

Study Arms (2)

Men and Mediterranean diet

EXPERIMENTAL

Men who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.

Other: Controlled nutritional intervention based on the Mediterranean diet

Women and Mediterranean diet

EXPERIMENTAL

Women who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.

Other: Controlled nutritional intervention based on the Mediterranean diet

Interventions

Controlled nutritional intervention based on the Mediterranean diet OTHER

Men are assigned to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet (MedDiet) in which all foods and drinks are provided. The respective percentages of kcal derived from lipids, carbohydrates, protein and alcohol are respectively of 32%, 48%, 15% and 5%. Habitual energy intake of each participant is established by averaging energy requirements estimated by a validated food-frequency questionnaire (FFQ) and energy needs as determined by the Harris-Benedict formula. Body weight is measured on weekdays and total energy provided is revised if necessary for minimizing body weight fluctuations. This intervention period is preceded by a 4 weeks uncontrolled run-in period based on the Canada's Food Guide.

Men and Mediterranean diet

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and premenopausal women from de Quebec City metropolitan area.
• Slightly elevated LDL-cholesterol concentrations (3.4-4.9 mM) or total cholesterol to HDL-C ratio ≥ 5.0
• At least one of the four following factors of the metabolic syndrome: 1) waist circumference \> 94 cm in men and \> 80 cm in women; 2) TG \> 1.7 mmol/L; 3) fasting glycemia between 6.1 and 6.9 mmol/L and 4) blood pressure concentrations ≥ 130 / 85 mm Hg.
• Age: between 25 to 50 years
• Stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study
• In women, a regular menstrual cycle for the last 3 months

You may not qualify if:

• Subjects with endocrine disorders, cardiovascular events, type 1 or 2 diabetes and those using medication that could affect dependent variables measured (namely lipid-lowering, hypoglycemic, insulin sensitizers and anti hypertensive medication)
• Smokers
• Subjects with history of alcoholism
• Subjects with food allergies or food aversion that could impede compliance to the Mediterranean diet
• Pregnant women and those using systemic hormonal contraceptives

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Québec, Quebec, G1V0A6, Canada

Location

Related Publications (4)

• Bedard A, Lamarche B, Corneau L, Dodin S, Lemieux S. Sex differences in the impact of the Mediterranean diet on systemic inflammation. Nutr J. 2015 May 12;14:46. doi: 10.1186/s12937-015-0035-y.

  PMID: 25962728 DERIVED

• Bedard A, Corneau L, Lamarche B, Dodin S, Lemieux S. Sex-related differences in the effects of the mediterranean diet on glucose and insulin homeostasis. J Nutr Metab. 2014;2014:424130. doi: 10.1155/2014/424130. Epub 2014 Oct 9.

  PMID: 25371817 DERIVED

• Bedard A, Tchernof A, Lamarche B, Corneau L, Dodin S, Lemieux S. Effects of the traditional Mediterranean diet on adiponectin and leptin concentrations in men and premenopausal women: do sex differences exist? Eur J Clin Nutr. 2014 May;68(5):561-6. doi: 10.1038/ejcn.2014.27. Epub 2014 Mar 5.

  PMID: 24595221 DERIVED

• Bedard A, Dodin S, Corneau L, Lemieux S. Impact of the traditional Mediterranean diet on the Framingham risk score and the metabolic syndrome according to sex. Metab Syndr Relat Disord. 2014 Mar;12(2):95-101. doi: 10.1089/met.2012.0076. Epub 2014 Jan 17.

  PMID: 24438432 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Multiple Endocrine Neoplasia Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Simone Lemieux, Ph.D., Dt.P.

  Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: October 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 7, 2011

Record last verified: 2011-10

Locations

CA (1)