Ramon Estruch1, Miguel Angel Martínez-González2, Dolores Corella3, Jordi Salas-Salvadó4, Montserrat Fitó5, Gemma Chiva-Blanch6, Miquel Fiol7, Enrique Gómez-Gracia8, Fernando Arós9, José Lapetra10, Lluis Serra-Majem11, Xavier Pintó12, Pilar Buil-Cosiales13, José V Sorlí14, Miguel A Muñoz15, Josep Basora-Gallisá16, Rosa María Lamuela-Raventós17, Mercè Serra-Mir18, Emilio Ros18. 1. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi Sunyer, University of Barcelona, Barcelona, Spain. Electronic address: restruch@clinic.ub.es. 2. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine and Public Health, Universidad de Navarra-Institute of Health Research of Navarra, Pamplona, Spain. 3. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, School of Medicine, University of Valencia, Valencia, Spain. 4. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Human Nutrition Department, Hospital Universitari Sant Joan, Institut d'Investigació Sanitària Pere Virgili, University Rovira i Virgili, Reus, Spain. 5. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Cardiovascular and Nutrition Research Group, Institut de Recerca Hospital del Mar, Barcelona, Spain. 6. Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi Sunyer, University of Barcelona, Barcelona, Spain. 7. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Institute of Health Sciences, University of Balearic Islands and Hospital Son Espases, Palma de Mallorca, Spain. 8. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, University of Málaga, Málaga, Spain. 9. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Cardiology, University Hospital of Alava, Vitoria, Spain. 10. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center, Sevilla, Spain. 11. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Research Institute of Biomedical Research and Health Services and School of Medicine, University of Las Palmas de Gran Canaria, Spain. 12. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Spain. 13. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Primary Health Care Division, Institute of Health Research of Navarra, Pamplona, Spain. 14. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Preventive Medicine, School of Medicine, University of Valencia, Valencia, Spain; Primary Care Division, Valencia Institute of Health, Burjassot, Valencia, Spain. 15. Primary Health Care Division, Institut Català de la Salut and Idiap-Jordi Gol, Barcelona, Spain. 16. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Primary Health Care Division, Institut Català de la Salut and Idiap-Jordi Gol, Tarragona, Spain. 17. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Nutrition and Bromatology, School of Pharmacy, Xarxa de Referència en Tecnologia dels Aliments, Instituto de Investigación en Alimentación y Seguridad Alimentaria, University of Barcelona, Barcelona, Spain. 18. Centro de Investigación Biomédica en Red Fisiopatologia de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain; Department of Internal Medicine and Lipid Clinic, Department of Endocrinology and Nutrition, University of Barcelona, Barcelona, Spain.
Abstract
BACKGROUND: Because of the high density of fat, high-fat diets are perceived as likely to lead to increased bodyweight, hence health-care providers are reluctant to recommend them to overweight or obese individuals. We assessed the long-term effects of ad libitum, high-fat, high-vegetable-fat Mediterranean diets on bodyweight and waist circumference in older people at risk of cardiovascular disease, most of whom were overweight or obese. METHODS: PREDIMED was a 5 year parallel-group, multicentre, randomised, controlled clinical trial done in primary care centres affiliated to 11 hospitals in Spain. 7447 asymptomatic men (aged 55-80 years) and women (aged 60-80 years) who had type 2 diabetes or three or more cardiovascular risk factors were randomly assigned (1:1:1) with a computer-generated number sequence to one of three interventions: Mediterranean diet supplemented with extra-virgin olive oil (n=2543); Mediterranean diet supplemented with nuts (n=2454); or a control diet (advice to reduce dietary fat; n=2450). Energy restriction was not advised, nor was physical activity promoted. In this analysis of the trial, we measured bodyweight and waist circumference at baseline and yearly for 5 years in the intention-to-treat population. The PREDIMED trial is registered with ISRCTN.com, number ISRCTN35739639. FINDINGS: After a median 4·8 years (IQR 2·8-5·8) of follow-up, participants in all three groups had marginally reduced bodyweight and increased waist circumference. The adjusted difference in 5 year changes in bodyweight in the Mediterranean diet with olive oil group was -0·43 kg (95% CI -0·86 to -0·01; p=0·044) and in the nut group was -0·08 kg (-0·50 to 0·35; p=0·730), compared with the control group. The adjusted difference in 5 year changes in waist circumference was -0·55 cm (-1·16 to -0·06; p=0·048) in the Mediterranean diet with olive oil group and -0·94 cm (-1·60 to -0·27; p=0·006) in the nut group, compared with the control group. INTERPRETATION: A long-term intervention with an unrestricted-calorie, high-vegetable-fat Mediterranean diet was associated with decreases in bodyweight and less gain in central adiposity compared with a control diet. These results lend support to advice not restricting intake of healthy fats for bodyweight maintenance. FUNDING: Spanish Government, CIBERobn, Instituto de Salud Carlos III, Hojiblanca, Patrimonio Comunal Olivarero, California Walnut Commission, Borges SA, and Morella Nuts.
RCT Entities:
BACKGROUND: Because of the high density of fat, high-fat diets are perceived as likely to lead to increased bodyweight, hence health-care providers are reluctant to recommend them to overweight or obese individuals. We assessed the long-term effects of ad libitum, high-fat, high-vegetable-fat Mediterranean diets on bodyweight and waist circumference in older people at risk of cardiovascular disease, most of whom were overweight or obese. METHODS: PREDIMED was a 5 year parallel-group, multicentre, randomised, controlled clinical trial done in primary care centres affiliated to 11 hospitals in Spain. 7447 asymptomatic men (aged 55-80 years) and women (aged 60-80 years) who had type 2 diabetes or three or more cardiovascular risk factors were randomly assigned (1:1:1) with a computer-generated number sequence to one of three interventions: Mediterranean diet supplemented with extra-virgin olive oil (n=2543); Mediterranean diet supplemented with nuts (n=2454); or a control diet (advice to reduce dietary fat; n=2450). Energy restriction was not advised, nor was physical activity promoted. In this analysis of the trial, we measured bodyweight and waist circumference at baseline and yearly for 5 years in the intention-to-treat population. The PREDIMED trial is registered with ISRCTN.com, number ISRCTN35739639. FINDINGS: After a median 4·8 years (IQR 2·8-5·8) of follow-up, participants in all three groups had marginally reduced bodyweight and increased waist circumference. The adjusted difference in 5 year changes in bodyweight in the Mediterranean diet with olive oil group was -0·43 kg (95% CI -0·86 to -0·01; p=0·044) and in the nut group was -0·08 kg (-0·50 to 0·35; p=0·730), compared with the control group. The adjusted difference in 5 year changes in waist circumference was -0·55 cm (-1·16 to -0·06; p=0·048) in the Mediterranean diet with olive oil group and -0·94 cm (-1·60 to -0·27; p=0·006) in the nut group, compared with the control group. INTERPRETATION: A long-term intervention with an unrestricted-calorie, high-vegetable-fat Mediterranean diet was associated with decreases in bodyweight and less gain in central adiposity compared with a control diet. These results lend support to advice not restricting intake of healthy fats for bodyweight maintenance. FUNDING: Spanish Government, CIBERobn, Instituto de Salud Carlos III, Hojiblanca, Patrimonio Comunal Olivarero, California Walnut Commission, Borges SA, and Morella Nuts.
Authors: George A Bray; William E Heisel; Ashkan Afshin; Michael D Jensen; William H Dietz; Michael Long; Robert F Kushner; Stephen R Daniels; Thomas A Wadden; Adam G Tsai; Frank B Hu; John M Jakicic; Donna H Ryan; Bruce M Wolfe; Thomas H Inge Journal: Endocr Rev Date: 2018-04-01 Impact factor: 19.871
Authors: Carla Assaf-Balut; Nuria García de la Torre; Alejandra Duran; Manuel Fuentes; Elena Bordiú; Laura Del Valle; Cristina Familiar; Johanna Valerio; Inés Jiménez; Miguel A Herraiz; Nuria Izquierdo; María J Torrejon; Maria Ángeles Cuadrado; Isabel Ortega; Francisco J Illana; Isabelle Runkle; Paz de Miguel; Inmaculada Moraga; Carmen Montañez; Ana Barabash; Martín Cuesta; Miguel A Rubio; Alfonso L Calle-Pascual Journal: Ann Nutr Metab Date: 2018-12-14 Impact factor: 3.374