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.
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.
Lancet Diabetes Endocrinol. 2019 May;7(5):e6-e17. doi: 10.1016/S2213-8587(19)30074-9.
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inconsistent use of randomisation tables at another site; 866 [11·6%] participants were affected in total), we have withdrawn our previously published report and now report revised effect estimates based on reanalyses that do not rely exclusively on the assumption that all the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.
背景:由于脂肪密度高,高脂肪饮食被认为可能导致体重增加,因此医疗保健提供者不愿意向超重或肥胖者推荐这种饮食。我们评估了自由摄入的高脂肪、高蔬菜脂肪的地中海饮食对有心血管疾病风险的老年人的体重和腰围的长期影响,这些老年人大多数超重或肥胖。
方法:PREDIMED 是一项为期 5 年的平行组、多中心、随机、对照临床试验,在西班牙 11 家医院的基层医疗中心进行。7447 名无症状的男性(年龄 55-80 岁)和女性(年龄 60-80 岁)患有 2 型糖尿病或三种或更多心血管危险因素,他们被随机分配(1:1:1),使用计算机生成的数字序列,分配到三种干预措施之一:地中海饮食加特级初榨橄榄油(n=2543);地中海饮食加坚果(n=2454);或对照组(建议减少饮食中的脂肪;n=2450)。不建议限制能量摄入,也不提倡增加体力活动。2016 年,我们报告了 5 年来体重和腰围的变化,但由于随后发现的方案偏差(包括没有随机分组的家庭成员登记、在 11 个研究点中的一个点没有随机分组的一些参与者被分配到一个研究组,以及在另一个点明显不一致地使用随机分组表;共有 866[11.6%]名参与者受到影响),我们撤回了之前发表的报告,现在根据不依赖于所有参与者都被随机分配的假设的重新分析报告修订后的效果估计。在这项试验的分析中,我们在意向治疗人群中测量了基线和 5 年内每年的体重和腰围。PREDIMED 试验在 ISRCTN.com 上注册,编号为 ISRCTN35739639。
结果:在中位数 4.8 年(IQR 2.8-5.8)的随访后,所有三组参与者的体重都略有减轻,腰围增加。经过多变量调整,包括对倾向评分的调整和使用稳健方差估计器,橄榄油地中海饮食组 5 年体重变化的差异为-0.410kg(95%CI-0.830 至 0.010;p=0.056),坚果组为-0.016kg(-0.453 至 0.421;p=0.942),与对照组相比。橄榄油地中海饮食组 5 年腰围变化的调整差异为-0.466cm(-1.109 至 0.176;p=0.154),坚果组为-0.923cm(-1.604 至-0.241;p=0.008),与对照组相比。
结论:长期摄入不受限制热量的富含蔬菜脂肪的地中海饮食与控制饮食相比,体重没有明显差异,而且中央肥胖的增加证据较少。这些结果支持了不限制健康脂肪摄入以维持体重的建议。
资金:西班牙政府、CIBERobn、西班牙卡洛斯三世健康研究所、Hojiblanca、公共橄榄油遗产、加利福尼亚核桃委员会、Borges SA 和莫雷利亚坚果。
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