Effect of a high-fat Mediterranean diet on bodyweight and waist circumference: a prespecified secondary outcomes analysis of the PREDIMED randomised controlled trial
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 2016, we reported the 5 year changes in bodyweight and waist circumference, but because of a subsequently identified protocol deviation (including enrolment of household members without randomisation, assignment to a study group without randomisation of some participants at one of 11 study sites, and apparent inconsistent use of randomisation tables at another site; 866 [11·6%] participants were affected in total), we have withdrawn our previously published report and now report revised effect estimates based on reanalyses that do not rely exclusively on the assumption that all the participants were randomly assigned. 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. After multivariable adjustment, including adjustment for propensity scores and use of robust variance estimators, the difference in 5 year changes in bodyweight in the Mediterranean diet with olive oil group was -0·410 kg (95% CI -0·830 to 0·010; p=0·056) and in the nut group was -0·016 kg (-0·453 to 0·421; p=0·942), compared with the control group. The adjusted difference in 5 year changes in waist circumference was -0·466 cm (-1·109 to 0·176; p=0·154) in the Mediterranean diet with olive oil group and -0·923 cm (-1·604 to -0·241; p=0·008) 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 no significant difference in bodyweight and some evidence of 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.
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A high-fat, unrestricted-calorie Mediterranean diet was associated with little weight change and less central adiposity compared with a low-fat diet long term.
“In conclusion, high fat, unrestricted calories MD was associated with little weight changes and less central adiposity compared with low-fat diet long term [21].”
From Mediterranean Diet and Obesity-related Disorders: What is the Evidence? (2022) · cites this paper as [21]
In the PREDIMED trial, neither arm of ad libitum Mediterranean diet demonstrated a significant difference in body weight compared with a low-fat diet.
“In comparison with low-fat diet, neither arm of ad libitum MD demonstrated significant difference in body weight: −0.410 kg (95% CI −0.830 to 0.01; p = 0.056) for MD supplemented with olive oil and −0.016 kg (95% CI −0.453 to 0.421; p = 0.942) for MD supplemented with nuts.”
From Mediterranean Diet and Obesity-related Disorders: What is the Evidence? (2022) · cites this paper as [21]
In the PREDIMED trial, the Mediterranean diet was associated with less gain of central adiposity compared with a low-fat diet.
“There was evidence that MD was associated with less gain of central adiposity as shown by the adjusted difference in WC after 5 years of −0.466 cm (95% CI −1.109 to 0.176; p = 0.154) in MD with olive oil and −0.923 cm (95% CI −1.604 to −0.241; p = 0.008) in the nut group, compared with low-fat diet group.”
From Mediterranean Diet and Obesity-related Disorders: What is the Evidence? (2022) · cites this paper as [21]
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- Authors
- Estruch, R., Martínez-González, M. A., Corella, D., Salas-Salvadó, J., Fitó, M., Chiva-Blanch, G., Fiol, M., Gómez-Gracia, E., Arós, F., Lapetra, J., Serra-Majem, L., Pintó, X., Buil-Cosiales, P., Sorlí, J. V., Muñoz, M. A., Basora-Gallisá, J., Lamuela-Raventós, R. M., Serra-Mir, M., & Ros, E.
- Affiliations
- Universitat de València (ES)
- Instituto de Salud Carlos III (ES)
- ORCID
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2019-05
- Volume
- 7
- Issue
- 5
- Pages
- e6-e17
- ISSN
- 2213-8587 (ISSN-L)
- OpenAlex
- W4247966898
- Cited by
- 147
- References
- 29
- Citations by year
- 2026: 10 · 2025: 14 · 2024: 15 · 2023: 22 · 2022: 23 · 2021: 21 · 2020: 24 · 2019: 10 · 2018: 1 · 2017: 3 · 2016: 4
- FWCI
- 18.05
- Type
- journal article
- Language
- en
- Status
- Retracted
- Update notices
- retraction (2016-08-01)
- Open access
- closed
- Locations
- The Lancet Diabetes & Endocrinology (publishedVersion)
- Acceda (Universidad de Las Palmas de Gran Canaria) (submittedVersion)
- DIGITAL.CSIC (Spanish National Research Council (CSIC)) (submittedVersion)
- Funders
- Instituto de Salud Carlos III (RTIC G03/140, RTIC RD 06/0045)
- Ministerio de Ciencia e Innovación (AGL- 2009-13906-C02, AGL2010-22319-C03, AGL2013-49083-C3-1-R)
- Centro Nacional de Investigaciones Cardiovasculares (CNIC 06/2007)
- Generalitat de Catalunya
- Generalitat Valenciana (ACOMP06109, CS2010- AP-111, CS2011-AP-042, GVACOMP2010-181, GVACOMP2011-151)
- European Regional Development Fund (CP06/00100, P11/02505, PI 05/2584, PI 07/0473, PI04-2239, PI07/0240, PI07/0954, PI07/1138, PI10/01407, PI10/02658, PI11/01647)
- Consejería de Salud y Familias, Junta de Andalucía (PI0105/2007)
- Centro de Investigación Biomédica en Red-Fisiopatología de la Obesidad y Nutrición
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Health Sciences › Medicine › Physiology › Diet and metabolism studies
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Keywords
- Mediterranean diet, high-fat diet, body weight, waist circumference, extra virgin olive oil, nuts, older adults, overweight, obesity, cardiovascular risk, type 2 diabetes, PREDIMED trial, protocol deviations, intention-to-treat analysis, body composition, abdominal obesity, energy intake, physical activity, sedentary behavior, sleep duration
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