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The Medi-RIVAGE study (Mediterranean Diet, Cardiovascular Risks and Gene Polymorphisms): rationale, recruitment, design, dietary intervention and baseline characteristics of participants

Published online by Cambridge University Press:  02 January 2007

S Vincent
Affiliation:
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
M Gerber
Affiliation:
Cancer Research Centre, INSERM–CRLC (Cancer Research Centre) Val d'Aurelle, Montpellier, France
MC Bernard
Affiliation:
CDPA (Centre for Detection and Prevention of Arteriosclerosis), Timone University Hospital, Marseille, France
C Defoort
Affiliation:
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 Analytical Chemistry Laboratory, Faculty of Pharmacy, Marseille, France
A Loundou
Affiliation:
ORS (Health Regional Observatory) Provence-Alpes-Côte d'Azur, Marseille, France
H Portugal
Affiliation:
Analytical Chemistry Laboratory, Faculty of Pharmacy, Marseille, France
R Planells
Affiliation:
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
I Juhan-Vague
Affiliation:
Haematology Laboratory, INSERM EPI 99-36, Timone University Hospital, Marseille, France
P Charpiot
Affiliation:
Biochemistry Laboratory, Faculty of Pharmacy, Marseille, France
P Grolier
Affiliation:
UMMM (Metabolic Disease and Micronutrients Unit) Laboratory, Vitamin Group at INRA (National Institute of Agronomic Research), Clermont-Ferrand, France
MJ Amiot-Carlin
Affiliation:
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
P Vague
Affiliation:
CDPA (Centre for Detection and Prevention of Arteriosclerosis), Timone University Hospital, Marseille, France
D Lairon*
Affiliation:
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
*
*Corresponding author: Email denis.lairon@medecine.univ-mrs.fr
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Abstract

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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.

Type
Research Article
Copyright
Copyright © The Authors 2004

References

1Lopez, AD. Assessing the burden of mortality from cardiovascular diseases. World Health Statistics Quarterly 1993; 46 91–6.Google ScholarPubMed
2Murray, CJ, Lopez, AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet 1997; 349 1436–42.CrossRefGoogle ScholarPubMed
3Keys, A, Blackburn, HW, Menotti, A, Karvonen, MJ, Aravanis, C, Blackburn, H, et al. Coronary heart disease in seven countries. Summary. Circulation 1970; 41 I186–95.Google Scholar
4Keys, A, Menotti, A, Karvonen, MJ, Aravanis, C, Blackburn, H, Buzina, R, et al. The diet and 15-year death rate in the seven countries study. American Journal of Epidemiology 1986; 124 903–15.CrossRefGoogle ScholarPubMed
5Menotti, A, Blackburn, H, Kromhout, D, Nissinen, A, Fidanza, F, Giampaoli, S, et al. Changes in population cholesterol levels and coronary heart disease deaths in seven countries. European Heart Journal 1997; 18 566–71.CrossRefGoogle ScholarPubMed
6Hu, FB, Willett, WC. Diet and coronary heart disease: findings from the Nurses' Health Study and Health Professionals' Follow-up Study. Journal of Nutrition, Health & Aging 2001; 5 132–8.Google ScholarPubMed
7Tunstall-Pedoe, H, Kuulasmaa, K, Amouyel, P, Arveiler, D, Rajakangas, AM, Pajak, A. Myocardial infarction and coronary deaths in the World Health Organization MONICA Project. Registration procedures, event rates, and case-fatality rates in 38 populations from 21 countries in four continents. Circulation 1994; 90 583612.CrossRefGoogle ScholarPubMed
8Kushi, LH, Lenart, EB, Willett, WC. Health implications of Mediterranean diets in light of contemporary knowledge. 2. Meat, wine, fats, and oils. American Journal of Clinical Nutrition 1995; 61 1416S–27S.CrossRefGoogle ScholarPubMed
9Trichopoulou, A, Kouris-Blazos, A, Wahlqvist, ML, Gnardellis, C, Lagiou, P, Polychronopoulos, E, et al. Diet and overall survival in elderly people. British Medical Journal 1995; 311 1457–60.CrossRefGoogle ScholarPubMed
10Gerber, MJ, Scali, JD, Michaud, A, Durand, MD, Astre, CM, Dallongeville, J, et al. Profiles of a healthful diet and its relationship to biomarkers in a population sample from Mediterranean southern France. Journal of the American Dietetic Association 2000; 100 1164–71.CrossRefGoogle Scholar
11Scali, J, Richard, A, Gerber, M. Diet profiles in a population sample from Mediterranean southern France. Public Health Nutrition 2001; 4 173–82.CrossRefGoogle Scholar
12Ferro-Luzzi, A, James, WP, Kafatos, A. The high-fat Greek diet: a recipe for all?. European Journal of Clinical Nutrition 2002; 56 796809.CrossRefGoogle Scholar
13Stephens, NG, Parsons, A, Schofield, PM, Kelly, F, Cheeseman, K, Mitchinson, MJ. Randomised controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS). Lancet 1996; 347 781–6.CrossRefGoogle ScholarPubMed
14Dietary supplementation with n – 3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Lancet 1999; 354: 447–55.Google Scholar
15Yusuf, S, Dagenais, G, Pogue, J, Bosch, J, Sleight, P. Vitamin E supplementation and cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. New England Journal of Medicine 2000; 342 154–60.Google Scholar
16MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360: 2333.CrossRefGoogle Scholar
17Traeden, UI, Holm, L, Sandstrom, B, Andersen, PK, Jarden, M. Effectiveness of a dietary intervention strategy in general practice: effects on blood lipids, health and well-being. Public Health Nutrition 1998; 1 273–81.CrossRefGoogle ScholarPubMed
18Pham, TC, Colette, C, Monnier, L. Communication between regional dietetic software and USDA-SR12. In: Third International Food Data Conference. Back to Basics. Rome: Food and Agriculture Organization, 1999.Google Scholar
19Favier, JC, Ireland-Ripert, J, Toque, C, Feinberg, M. Répertoire général des aliments. Table de composition, 2nd ed. Paris: CIQUAL, 1995.Google Scholar
20Daures, JP, Gerber, M, Scali, J, Astre, C, Bonifacj, C, Kaaks, R. Validation of a food-frequency questionnaire using multiple-day records and biochemical markers: application of the triads method. Journal of Epidemiology and Biostatistics 2000; 5 109–15.Google ScholarPubMed
21Harbis, A, Defoort, C, Narbonne, H, Juhel, C, Senft, M, Latge, C, et al. Acute hyperinsulinism modulates plasma apolipoprotein B-48 triglyceride-rich lipoproteins in healthy subjects during the postprandial period. Diabetes 2001; 50 462–9.CrossRefGoogle ScholarPubMed
22Bligh, EG, Dyer, WG. Rapid method extraction and purification. Canadian Journal of Biochemistry and Physiology 1959; 57 911–7.CrossRefGoogle Scholar
23Lyan, B, Azais-Braesco, V, Cardinault, N, Tyssandier, V, Borel, P, Alexandre-Gouabau, MC, et al. Simple method for clinical determination of 13 carotenoids in human plasma using an isocratic high-performance liquid chromatographic method. Journal of Chromatography B: Biomedical Sciences and Applications 2001; 751 297303.CrossRefGoogle ScholarPubMed
24Singleton, VL, Rossi, JA. Colorimetry of total phenolics with phosphomolybdic–phosphotunstic acid reagents. American Journal of Enology and Viticulture 1965; 16 144–58.CrossRefGoogle Scholar
25Clauss, A. Gerinnungphysiologische schnellmethode zur destimmung des fibrinogens. Acta Haematologica 1957; 17 237–46.CrossRefGoogle Scholar
26Wilson, PW, D'Agostino, RB, Levy, D, Belanger, AM, Silbershatz, H, Kannel, WB. Prediction of coronary heart disease using risk factor categories. Circulation 1998; 97 1837–47.CrossRefGoogle ScholarPubMed
27Matthews, DR, Hosker, JP, Rudenski, AS, Naylor, BA, Treacher, DF, Turner, RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985; 28 412–9.CrossRefGoogle ScholarPubMed
28De Lorgeril, M, Renaud, S, Mamelle, N, Salen, P, Martin, JL, Monjaud, I, et al. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet 1994; 343 1454–9.CrossRefGoogle ScholarPubMed
29De 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; 99 779–85.CrossRefGoogle ScholarPubMed
30Bemelmans, WJ, Broer, J, de Vries, JH, Hulshof, KF, May, JF, Meyboom-De Jong, B. Impact of Mediterranean diet education versus posted leaflet on dietary habits and serum cholesterol in a high risk population for cardiovascular disease. Public Health Nutrition 2000; 3 273–83.CrossRefGoogle Scholar
31Bemelmans, WJ, Broer, J, Feskens, EJ, Smit, AJ, Muskiet, FA, Lefrandt, JD, et al. Effect of an increased intake of alpha-linolenic acid and group nutritional education on cardiovascular risk factors: the Mediterranean Alpha-linolenic Enriched Groningen Dietary Intervention (MARGARIN) study. American Journal of Clinical Nutrition 2002; 75 221–7.CrossRefGoogle ScholarPubMed
32Frikke-Schmidt, R, Nordestgaard, BG, Agerholm-Larsen, B, Schnohr, P, Tybjaerg-Hansen, A. Context-dependent and invariant associations between lipids, lipoproteins, and apolipoproteins and apolipoprotein E genotype. Journal of Lipid Research 2000; 41 1812–22.CrossRefGoogle ScholarPubMed
33Baier, LJ, Sacchettini, JC, Knowler, WC, Eads, J, Paolisso, G, Tataranni, PA, et al. An amino acid substitution in the human intestinal fatty acid binding protein is associated with increased fatty acid binding, increased fat oxidation, and insulin resistance. Journal of Clinical Investigation 1995; 95 1281–7.CrossRefGoogle ScholarPubMed
34Kastelein, JJ, Groenemeyer, BE, Hallman, DM, Henderson, H, Reymer, PW, Gagne, SE, et al. The Asn9 variant of lipoprotein lipase is associated with the –93G promoter mutation and an increased risk of coronary artery disease. The Regress Study Group. Clinical Genetics 1998; 53: 2733.CrossRefGoogle Scholar
35Martin, A, Azais-Braesco, V, Couet, C, Cynober, L, Gueguen, L, Lairon, D, et al. Apports nutritionnels conseillés pour la population française. Paris: Cnerna CNRS, 2001.Google Scholar
36Gerber, M, Siari, S, Michaud, A, Scali, J. Alimentation Méditerranéenne et santé. MEDHEA. Résultats de l'Hérault. Actualité en Diététique 1999; 35 1391–6.Google Scholar
37Jost, JP, Simon, C, Nuttens, MC, Bingham, A, Ruidavets, JB, Cambou, JP, et al. Comparison of dietary patterns between population samples in the three French MONICA nutritional surveys. Revue d'Epidemiologie et de Santé Publique 1990; 38 517–23.Google ScholarPubMed
38Mennen, LI, Bertrais, S, Galan, P, Arnault, N, Potier de Couray, G, Hercberg, S. The use of computerised 24 h dietary recalls in the French SU.VI.MAX Study: number of recalls required. European Journal of Clinical Nutrition 2002; 56 659–65.CrossRefGoogle ScholarPubMed
39Saintot, M, Astre, C, Scali, J, Gerber, M. Within-subjects seasonal variation and determinants of inter-individual variations of plasma beta-carotene. International Journal for Vitamin and Nutrition Research 1995; 65 169–74.Google ScholarPubMed
40Relative validity and reproducibility of a diet history questionnaire in Spain. III. Biochemical markers. EPIC Group of Spain. European Prospective Investigation into Cancer and Nutrition. International Journal of Epidemiology 1997; 26 S110–7.CrossRefGoogle Scholar
41Kaaks, R, Slimani, N, Riboli, E. Pilot phase studies on the accuracy of dietary intake measurements in the EPIC project: overall evaluation of results. European Prospective Investigation into Cancer and Nutrition. International Journal of Epidemiology 1997; 26 S26–36.CrossRefGoogle ScholarPubMed
42Homocysteine Lowering Trialists' Collaboration. Lowering blood homocysteine with folic acid based supplements: meta- analysis of randomised trials. Homocysteine Lowering Trialists' Collaboration. British Medical Journal 1998; 316 894–8.CrossRefGoogle Scholar
43Rimm, EB, Ascherio, A, Giovannucci, E, Spiegelman, D, Stampfer, MJ, Willett, WC. Vegetable, fruit, and cereal fiber intake and risk of coronary heart disease among men. Journal of the American Medical Association 1996; 275 447–51.CrossRefGoogle ScholarPubMed