a1 Unit 476 – Human Nutrition and Lipids at INSERM (National Institute of Health and Medical Research), Faculty of Medicine Timone, Méditerranée University, 27 boulevard Jean Moulin, F-13385 Marseille Cedex 5, France
a2 Cancer Research Centre, INSERM–CRLC (Cancer Research Centre) Val d'Aurelle, Montpellier, France
a3 CDPA (Centre for Detection and Prevention of Arteriosclerosis), Timone University Hospital, Marseille, France
a4 Analytical Chemistry Laboratory, Faculty of Pharmacy, Marseille, France
a5 ORS (Health Regional Observatory) Provence-Alpes-Côte d'Azur, Marseille, France
a6 Haematology Laboratory, INSERM EPI 99-36, Timone University Hospital, Marseille, France
a7 Biochemistry Laboratory, Faculty of Pharmacy, Marseille, France
a8 UMMM (Metabolic Disease and Micronutrients Unit) Laboratory, Vitamin Group at INRA (National Institute of Agronomic Research), Clermont-Ferrand, France
Objective: To report the rationale, recruitment, design, dietary intervention and baseline characteristics of participants in the Medi-RIVAGE study (Mediterranean Diet, Cardiovascular Risks and Gene Polymorphisms).
Design: A randomised, parallel trial comparing a new nutritional programme with a conventional programme.
Setting: Centre for Detection and Prevention of Arteriosclerosis, Timone University Hospital, Marseille, France, and collaborating teams.
Subjects: Two hundred and twelve male and female volunteers with at least one cardiovascular risk factor.
Intervention: A Mediterranean-type diet characterised mainly by the quality of fatty acids, amount of fish, vegetable foodstuffs and fibre was proposed and compared with a usually prescribed, low-fat/cholesterol diet. Body mass index, fasting lipids and lipoproteins, apolipoproteins, glucose, insulin and homocysteine were the main outcome measures. Gene polymorphisms of interest were determined.
Results: Characteristics of men in the two arms were comparable with regard to sociodemographic variables, and clinical and biological cardiovascular risk factors. There were few differences between the groups of women (cholesterol-related parameters, P < 0.05). There was no difference between arms in allelic distribution of the gene polymorphisms studied. Saturated fat and protein intakes were high while carbohydrate and fibre intakes were low, but with no difference between arms. Overall, the nutritional markers were comparable in both arms with few exceptions. Correlations between nutritional intakes and plasma nutrient levels ranged from 0.19 (β-carotene) to 0.47 (folate).
Conclusions: The comparability of the two arms is notable and warrants a low risk of biases. Current diet departs from the traditional Mediterranean one. The assessment of nutritional intake is validated by correlations obtained between dietary intake and relevant biomarkers. This will be important to estimate participant compliance and to analyse intervention data.
(Received March 17 2003)
(Accepted October 01 2003)