Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial
Abstract
Background The rapid emergence of coronary artery disease (CAD) in south Asian people is not explained by conventional risk factors. In view of cardioprotective effects of a Mediterranean style diet rich in alpha-linolenic acid, we assessed the benefits of this diet for patients at high risk of CAD.Methods We did a randomised, single-blind trial in 1000 patients with angina pectoris, myocardial infarction, or surrogate risk factors for CAD. 499 patients were allocated to a diet rich in whole grains, fruits, vegetables, walnuts, and almonds. 501 controls consumed a local diet similar to the step I National Cholesterol Education Program (NCEP) prudent diet.Findings The intervention group consumed more fruits, vegetables, legumes, walnuts, and almonds than did controls (573 g [SD 127] vs 231 g [19] per day p<0.001). The intervention group had an increased intake of whole grains and mustard or soy bean oil. The mean intake of alpha-linolenic acid was two-fold greater in the intervention group (1.8 g [SD 0.4] vs 0.8 g [0.2] per day, p<0.001). Total cardiac end points were significantly fewer in the intervention group than the controls (39 vs 76 events, p<0.001). Sudden cardiac deaths were also reduced (6 vs 16, p=0.015), as were non-fatal myocardial infarctions (21 vs 43, p<0.001). We noted a significant reduction in serum cholesterol concentration and other risk factors in both groups, but especially in the intervention diet group. In the treatment group, patients with pre-existing CAD had significantly greater benefits compared with such patients in the control group.Interpretation An Indo-Mediterranean diet that is rich in alpha-linolenic acid might be more effective in primary and secondary prevention of CAD than the conventional step I NCEP prudent diet.
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In a randomized clinical trial by Singh and colleagues, an Indo-Mediterranean diet in 1,000 Indian patients at high risk or with existing coronary heart disease found a significant reduction in total cardiac end points.
“In another randomized clinical trial, Singh and colleagues tested a “Indo-Mediterranean diet,” rich in whole grains, fruits, vegetables, walnuts, almonds, mustard, or soybean oil, in 1,000 Indian patients at high risk or with existing coronary heart disease, and found a significant reduction in total cardiac end points.”
From Health Benefits of the Mediterranean Diet: Metabolic and Molecular Mechanisms (2018) · cites this paper as [23]
Compared with patients randomized to a step I National Cholesterol Education Program prudent diet, those following the Indo-Mediterranean diet rich in α-linolenic acid experienced an approximate 50% reduction in the rate of nonfatal myocardial infarction and an approximate 60% reduction in the rate of sudden cardiac death.
“Compared with patients randomized to a step I National Cholesterol Education Program prudent diet, those following the Indo-Mediterranean diet rich in α-linolenic acid experienced an approximate 50% reduction in the rate of nonfatal myocardial infarction and an approximate 60% reduction in the rate of sudden cardiac death (23).”
From Health Benefits of the Mediterranean Diet: Metabolic and Molecular Mechanisms (2018) · cites this paper as [23]
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The French paradox: lessons for other countries
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“randomised 605 French patients with CHD to either a diet rich in fruit, vegetables, nuts and α linolenic acid-rich margarine or their usual diet (a prudent Western diet). After two and four years, the intervention diet group had significantly reduced cardiovascular end points, although CHD risk factors were comparable…”
BackgroundNordmann, A. J., Suter, K., Bucher, H. C., Shai, I., Tuttle, K. R., Estruch, R., & Briel, M. (2011) · The American Journal of Medicine · doi:10.1016/j.amjmed.2011.04.024 · Cited by 304 · see citing works
Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease
Abdelhamid, A. S., Brown, T. J., Brainard, J. S., Biswas, P., Thorpe, G. C., Moore, H. J., Deane, K. H., Summerbell, C. D., Worthington, H. V., Song, F., et al. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003177.pub5 · Cited by 295 · see citing works
The Mediterranean Diet: From an Environment-Driven Food Culture to an Emerging Medical Prescription
Lăcătușu, C.-M., Grigorescu, E.-D., Floria, M., Onofriescu, A., & Mihai, B. M. (2019) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph16060942 · Cited by 308 · see citing works
“Patients following the “Indo-Mediterranean diet” had an approximately 60% reduction in the rate of cardiovascular death and an approximately 50% reduction in the risk for non-fatal myocardial infarction [45].”
BackgroundDiet and Alzheimer’s disease risk factors or prevention: the current evidence
Solfrizzi, V., Panza, F., Frisardi, V., Seripa, D., Logroscino, G., Imbimbo, B. P., & Pilotto, A. (2011) · Expert Review of Neurotherapeutics · doi:10.1586/ern.11.56 · Cited by 298 · see citing works
Griffiths, K., Aggarwal, B. B., Singh, R. B., Buttar, H. S., Wilson, D. W., & Meester, F. D. (2016) · Diseases · doi:10.3390/diseases4030028 · Cited by 298 · see citing works
O'Keefe, J. H., & Cordain, L. (2004) · Mayo Clinic Proceedings · doi:10.4065/79.1.101 · Cited by 289 · see citing works
n−3 Fatty acids and the metabolic syndrome
Carpentier, Y., Portois, L., & Malaisse, W. J. (2006) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/83.6.1499s · Cited by 283 · see citing works
“Although diets with an increased content of plant -linolenic acid (18:3n 3, or ALA) appear largely beneficial in secondary cardiovascular prevention (41, 42), it is difficult to determine whether ALA has a direct effect on glucose or lipid homeostasis, on inflammation, or on antioxidant status.”
BackgroundWarensjö, E., Sundström, J., Vessby, B. O., Cederholm, T., & Risérus, U. (2008) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/88.1.203 · Cited by 280 · see citing works
“Ecologic studies, such as the Seven Countries Study (1); some prospective studies (2–5); some long-term intervention studies (6, 7); and secondary prevention studies (8, 9) suggest that saturated fatty acids (SFAs) increase, whereas unsaturated fat decrease the risk of CHD.”
Omega-3 fatty acids and cardiovascular disease: A case for omega-3 index as a new risk factor
Harris, W. S. (2007) · Pharmacological Research · doi:10.1016/j.phrs.2007.01.013 · Cited by 278 · see citing works
“In these two studies [19,20], the active agent(s) cannot be identified with confidence because so many dietary variables differed between groups.”
BackgroundRed Yeast Rice for Dyslipidemia in Statin-Intolerant Patients: A Randomized Trial
Becker, D. J., Gordon, R. Y., Halbert, S. C., French, B., Morris, P. B., & Rader, D. J. (2009) · Annals of Internal Medicine · doi:10.7326/0003-4819-150-12-200906160-00006 · Cited by 275 · see citing works
Backer, G. D., Ambrosioni, E., Broch-Johnsen, K., Brotons, C., Cífková, R., Dallongeville, J., Ebrahim, S. B. J., Færgeman, O., Graham, I. D., Mancia, G., et al. (2003) · European Journal of Cardiovascular Prevention & Rehabilitation · doi:10.1097/00149831-200312001-00001 · Cited by 273 · see citing works
Vincent-Baudry, S., Defoort, C., Gerber, M., Bernard, M., Verger, P., Helal, O., Portugal, H., Planells, R., Grolier, P., Amiot, M. J., et al. (2005) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/82.5.964 · Cited by 274 · see citing works
“Interestingly, the reduction in LDL cholesterol after 3 mo tended to be greater with the Med diet (P 0.09 for time-by-group interaction) than with the low-fat diet, which agreed with the observations of the MARGARIN (20) and the Indo-Mediterranean (18) studies.”
BackgroundResultInfluentialMetabolic and Vascular Effect of the Mediterranean Diet
Tuttolomondo, A., Simonetta, I., Daidone, M., Mogavero, A., Ortello, A., & Pinto, A. V. (2019) · International Journal of Molecular Sciences · doi:10.3390/ijms20194716 · Cited by 269 · see citing works
“A recent meta-analysis [252] indicated that an absolute adherence to the Mediterranean diet, independently from the population analysed, defined a lower risk of stroke both ischemic and haemorrhagic (about 16% for each four points higher in the MedDiet Score).”
Jenkins, D., Kendall, C., Marchie, A., Faulkner, D., Wong, J., de Souza, R., Emam, A., Parker, T., Vidgen, E., Trautwein, E., et al. (2005) · American Journal of Clinical Nutrition · doi:10.1093/ajcn.81.2.380 · Cited by 285 · see citing works
Mediterranean diet and survival among patients with coronary heart disease in Greece
Trichopoulou, A., Bamia, C., & Trichopoulos, D. (2005) · Archives of Internal Medicine · doi:10.1001/archinte.165.8.929 · Cited by 266 · see citing works
Papadaki, A., Nolen‐Doerr, E., & Mantzoros, C. S. (2020) · Nutrients · doi:10.3390/nu12113342 · Cited by 266 · see citing works
“Six studies reported on the effect of the MD on pharmacologic treatment of MetSyn components and/or related comorbidities [47,48,53,62,68,91,93].”
BackgroundResultWhat is the role of α‐linolenic acid for mammals?
Sinclair, A. J., Attar‐Bashi, N. M., & Li, D. (2002) · Lipids · doi:10.1007/s11745-002-1008-x · Cited by 270 · see citing works
Iestra, J. A., Kromhout, D., van der Schouw, Y. T., Grobbee, D. E., Boshuizen, H. C., & van Staveren, W. A. (2005) · Circulation · doi:10.1161/circulationaha.104.503995 · Cited by 262 · see citing works
“40 Cohort studies in the general population have shown that mortality is 30% to 50% lower in normal-weight individuals than in their obese peers, 80 although this difference decreases with age.”
The Mediterranean Diet and Mortality — Olive Oil and Beyond
Hu, F. B. (2003) · New England Journal of Medicine · doi:10.1056/nejmp030069 · Cited by 256 · see citing works
The influence of olive oil on human health: not a question of fat alone
Pérez‐Jiménez, F., Ruano, J., Pérez‐Martínez, P., Lopez‐Segura, F., & López‐Miranda, J. (2007) · Molecular Nutrition & Food Research · doi:10.1002/mnfr.200600273 · Cited by 257 · see citing works
Therapeutic Benefits and Dietary Restrictions of Fiber Intake: A State of the Art Review
Ioniță-Mîndrican, C.-B., Ziani, K., Mititelu, M., Oprea, E., Neacșu, S. M., Moroșan, E., Dumitrescu, D. E., Roșca, A. C., Drăgănescu, D., & Negrei, C. (2022) · Nutrients · doi:10.3390/nu14132641 · Cited by 281 · see citing works
Mediterranean Diet, Inflammatory and Metabolic Biomarkers, and Risk of Alzheimer's Disease
Gu, Y., Luchsinger, J. A., Stern, Y., & Scarmeas, N. (2010) · Journal of Alzheimer s Disease · doi:10.3233/jad-2010-100897 · Cited by 244 · see citing works
“Similarly, vascular variables are also likely to be in the causal pathway between MeDi and AD considering the strong evidence relating the MeDi to lower risk of vascular risk factors [43], which may contribute to increased risk of AD [44].”
BackgroundBrouwer, I. A., Katan, M., & Zock, P. L. (2004) · Journal of Nutrition · doi:10.1093/jn/134.4.919 · Cited by 240 · see citing works
Culture: The missing link in health research
Singer, M. K., Dressler, W. W., George, S., Baquet, C. R., Bell, R. A., Burhansstipanov, L., Burke, N. J., Dibble, S. L., Elwood, W. N., Garro, L. C., et al. (2016) · Social Science & Medicine · doi:10.1016/j.socscimed.2016.07.015 · Cited by 237 · see citing works
Managing Abnormal Blood Lipids
Fletcher, B. J., Berra, K. A., Ades, P., Braun, L. T., Burke, L. E., Durstine, J. L., Fair, J. M., Fletcher, G. F., Goff, D. C., Hayman, L. L., et al. (2005) · Circulation · doi:10.1161/circulationaha.105.169180 · Cited by 236 · see citing works
The association between Mediterranean diet adherence and Parkinson's disease
Alcalay, R. N., Gu, Y., Mejia‐Santana, H., Cote, L., Marder, K. S., & Scarmeas, N. (2012) · Movement Disorders · doi:10.1002/mds.24918 · Cited by 228 · see citing works
Diet and inflammation: a link to metabolic and cardiovascular diseases
Esposito, K., & Giugliano, D. (2005) · European Heart Journal · doi:10.1093/eurheartj/ehi605 · Cited by 233 · see citing works
Khan, S. U., Khan, M. U., Riaz, H., Valavoor, S., Zhao, D., Vaughan, L., Okunrintemi, V., Riaz, I. B., Khan, M. S., Kaluski, E., et al. (2019) · Annals of Internal Medicine · doi:10.7326/m19-0341 · Cited by 216 · see citing works
Flaxseed and Cardiovascular Risk
Bloedon, L. T., & Szapary, P. O. (2004) · Nutrition Reviews · doi:10.1111/j.1753-4887.2004.tb00002.x · Cited by 217 · see citing works
Martínez-González, M. Á., & Sánchez-Villegas, A. (2004) · European Journal of Epidemiology · doi:10.1023/b:ejep.0000013351.60227.7b · Cited by 215 · see citing works
“The Indo-Mediterranean Trial [33] found a 52% relative reduction in total cardiac endpoints with a experimental diet rich in fruit, vegetables, nuts, whole grains and mustard seed or soy bean oil.”
BackgroundEffects of the Mediterranean Diet on Cardiovascular Outcomes—A Systematic Review and Meta-Analysis
Liyanage, T., Ninomiya, T., Wang, A., Neal, B., Jun, M., Wong, M. G., Jardine, M., Hillis, G. S., & Perkovic, V. (2016) · PLOS ONE · doi:10.1371/journal.pone.0159252 · Cited by 210 · see citing works
“Among these, 477 major cardiovascular events were reported from three trials[13,14,19] and 693 deaths from five trials[13,14,18–20].”
BackgroundMethodInfluentialHealth benefits of plant-derived α-linolenic acid
Rajaram, S. (2014) · American Journal of Clinical Nutrition · doi:10.3945/ajcn.113.071514 · Cited by 211 · see citing works
Prevention and control of type 2 diabetes by Mediterranean diet: A systematic review
Esposito, K., Maiorino, M. I., Ceriello, A., & Giugliano, D. (2010) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2010.04.019 · Cited by 208 · see citing works
Omega-3 fatty acids and cardiovascular disease
von Schacky, C. (2007) · Current Opinion in Clinical Nutrition & Metabolic Care · doi:10.1097/mco.0b013e3280127af0 · Cited by 207 · see citing works
Nutritional strategies in the prevention and treatment of metabolic syndrome
Feldeisen, S. E., & Tucker, K. L. (2007) · Applied Physiology, Nutrition, and Metabolism · doi:10.1139/h06-101 · Cited by 206 · see citing works
“There is considerable evidence that a Mediterranean dietary pattern may have beneficial effects on cardiovascular disease risk (de Lorgeril et al. 1999; Singh et al. 2002), MetS (Esposito et al. 2004), and all-cause mortality (Trichopoulou et al. 2003).”
BackgroundDiet and risk of ischemic heart disease in India
Rastogi, T., Reddy, K. S., Vaz, M. A. P., Spiegelman, D. L., Prabhakaran, D., Willett, W. C., Stampfer, M. J., & Ascherio, A. (2004) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/79.4.582 · Cited by 204 · see citing works
Mediterranean Diet and Cardiovascular Disease Prevention: What Do We Know?
Salas‐Salvadó, J., Becerra‐Tomás, N., García-Gavilán, J. F., Bulló, M., & Barrubés, L. (2018) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2018.04.006 · Cited by 199 · see citing works
Alcohol Consumption and Risk for Coronary Heart Disease in Men With Healthy Lifestyles
Mukamal, K. J., Chiuve, S. E., & Rimm, E. B. (2006) · Archives of Internal Medicine · doi:10.1001/archinte.166.19.2145 · Cited by 195 · see citing works
“For example, we know of no clinical trials to support weight loss or smokingcessation for primary prevention of MI, and diet has primarily been tested in patients with established coronary heart disease (CHD).(6,7) Because of the risks associated with high alcohol intake, clinical guidelines generally do not recommend…”
MethodDietary enrichment of edible insects with omega 3 fatty acids
Oonincx, D. G. A. B., Laurent, S., Veenenbos, M., & van Loon, J. J. A. (2019) · Insect Science · doi:10.1111/1744-7917.12669 · Cited by 208 · see citing works
“Later studies included the plant based fatty acid C18:3n3 (alphalinolenic acid; ALA) and indicated that also ALA can be an effective way to achieve desired health effects in humans (Mantzioris et al., 2000; Bemelmans et al., 2002; Singh et al., 2002; Zhao et al., 2004; Campos et al., 2008).”
BackgroundA Quantitative Analysis of Fish Consumption and Coronary Heart Disease Mortality
König, A., Bouzan, C., Cohen, J. T., We, C., Kris‐Etherton, P. M., Gray, G. C., LAWRENCE, R., Savitz, D. A., & Teutsch, S. M. (2005) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2005.07.001 · Cited by 190 · see citing works
Mediterranean Diet and Cardiovascular Risk Factors: A Systematic Review
Grosso, G., Mistretta, A., Frigiola, A., Gruttadauria, S., Biondi, A., Basile, F., Vitaglione, P., D’Orazio, N., & Galvano, F. (2013) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2011.596955 · Cited by 190 · see citing works
“In fact, several works did not include in their definition some key components of the diet such as olive oil, nuts, or wholegrain cereals (Singh et al., 2002), or they focused the intervention only on one of these components (Estruch et al., 2006; Fito et al., 2007; SalasSalvado et al., 2008a,…”
BackgroundInfluentialMicrobiome-Mediated Effects of the Mediterranean Diet on Inflammation
Bailey, M. A., & Holscher, H. D. (2018) · Advances in Nutrition · doi:10.1093/advances/nmy013 · Cited by 187 · see citing works
Jenkins, D. J., Kendall, C. W., Faulkner, D. A., Nguyen, T., Kemp, T., Marchie, A., Wong, J. M., de Souza, R., Emam, A., Vidgen, E., et al. (2006) · The American Journal of Clinical Nutrition · doi:10.1093/ajcn.83.3.582 · Cited by 184 · see citing works
Adherence to a Mediterranean diet and Alzheimer’s disease risk in an Australian population
Gardener, S. L., Gu, Y., Rainey‐Smith, S. R., Keogh, J. B., Clifton, P. M., Mathieson, S., Taddei, K., Mondal, A., Ward, V., Scarmeas, N., et al. (2012) · Translational Psychiatry · doi:10.1038/tp.2012.91 · Cited by 183 · see citing works
Lasa, A., Miranda, J., Bulló, M., Casas, R. M., Salas‐Salvadó, J., Larretxi, I., Estruch, R., Ruíz-Gutiérrez, V., & Portillo, M. P. (2014) · European Journal of Clinical Nutrition · doi:10.1038/ejcn.2014.1 · Cited by 182 · see citing works
Dietary fats, carbohydrate, and progression of coronary atherosclerosis in postmenopausal women
Mozaffarian, D., Rimm, E. B., & Herrington, D. M. (2004) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/80.5.1175 · Cited by 183 · see citing works
“Lyon Diet-Heart, 1994 (46) 61 women, 544”
Impact of dietary and lifestyle factors on the prevalence of hypertension in Western populations
Geleijnse, J. M. (2004) · European Journal of Public Health · doi:10.1093/eurpub/14.3.235 · Cited by 181 · see citing works
Kabboul, N. N., TOMLINSON, G. A., Francis, T., Grace, S. L., Chaves, G., Rac, V. E., Daou-Kabboul, T., BIELECKI, J. M., Alter, D. A., & Krahn, M. D. (2018) · Journal of Clinical Medicine · doi:10.3390/jcm7120514 · Cited by 180 · see citing works
What do review papers conclude about food and dietary patterns?
Wirfält, E., Drake, I., & Wallström, P. (2013) · Food & Nutrition Research · doi:10.3402/fnr.v57i0.20523 · Cited by 178 · see citing works
The Health Benefiting Mechanisms of Virgin Olive Oil Phenolic Compounds
Parkinson, L., & Cicerale, S. (2016) · Molecules · doi:10.3390/molecules21121734 · Cited by 179 · see citing works
Mediterranean Dietary Patterns and Cardiovascular Health
Shen, J., Wilmot, K. A., Ghasemzadeh, N., Molloy, D. L., Burkman, G. M., Mekonnen, G., Góngora, M. C., Quyyumi, A. A., & Sperling, L. S. (2015) · Annual Review of Nutrition · doi:10.1146/annurev-nutr-011215-025104 · Cited by 174 · see citing works
Kremmyda, L.-S., TVRZICKÁ, E., Staňková, B., & Žák, A. (2011) · Biomedical Papers · doi:10.5507/bp.2011.052 · Cited by 170 · see citing works
Viguiliouk, E., Kendall, C. W. C., Mejía, S. B., Cozma, A. I., Ha, V., Mirrahimi, A., Jayalath, V. H., Augustin, L. S. A., Chiavaroli, L., Leiter, L. A., et al. (2014) · PLoS ONE · doi:10.1371/journal.pone.0103376 · Cited by 171 · see citing works
“In a systematic review of 5 randomized controlled trials [39], as well as several individual randomized controlled trials [40–43] including people with type 2 diabetes, a Mediterranean dietary pattern emphasizing nuts showed decreases in HbA1c (from 20.”
BackgroundUsefulness of Omega-3 Fatty Acids and the Prevention of Coronary Heart Disease
Harper, C. R., & Jacobson, T. A. (2005) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2005.07.071 · Cited by 160 · see citing works
- Authors
- Singh, R. B., Dubnov, G., Niaz, M. A., Ghosh, S., Singh, R., Rastogi, S. S., Manor, O., Pella, D., & Berry, E. M.
- Affiliations
- Teerthanker Mahaveer Medical College & Research Centre (IN)
- Hebrew University of Jerusalem (IL)
- Corresponding author
- Berry, Elliot M
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2002-11
- Volume
- 360
- Issue
- 9344
- Pages
- 1455-1461
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2093983853
- Cited by
- 663
- References
- 39
- Citations by year
- 2026: 8 · 2025: 12 · 2024: 11 · 2023: 14 · 2022: 12 · 2021: 25 · 2020: 11 · 2019: 19 · 2018: 25 · 2017: 18 · 2016: 19 · 2015: 25 · 2014: 25 · 2013: 21 · 2012: 37
- FWCI
- 57.17
- Type
- journal article
- Language
- en
- Update notices
- expression_of_concern (2005-07-30)
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Risk Factors
- Keywords
- coronary artery disease, alpha-linolenic acid, dietary intervention, angina pectoris, myocardial infarction, sudden cardiac death, whole grains, nuts, fruits and vegetables, serum cholesterol, secondary prevention, South Asian populations
- MeSH terms
- Angina Pectoris, Coronary Artery Disease, Female, Humans, Male, Middle Aged, Myocardial Infarction, Risk Factors, Proportional Hazards Models, Survival Analysis, Single-Blind Method, Disease Progression, Diet, Mediterranean
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