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. 2016 Aug;4(8):666-676. doi: 10.1016/S2213-8587(16)30085-7. Epub 2016 Jun 6.
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.
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高脂肪饮食。我们评估了随意摄入富含脂肪、富含蔬菜脂肪的地中海饮食对心血管疾病高危老年人的体重和腰围的长期影响，其中大多数人超重或肥胖。
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 家医院附属的初级保健中心进行。7447 名无症状男性（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，随机分配（1:1:1）到以下三种干预措施之一：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，也不鼓励增加体力活动。在这项临床试验分析中，我们在意向治疗人群中测量了基线和每年 5 年的体重和腰围。PREDIMED 试验在 ISRCTN.com 注册，编号 ISRCTN35739639。
结果：经过中位数为 4.8 年（IQR 2.8-5.8）的随访，所有三组参与者的体重均略有减轻，腰围增加。与对照组相比，橄榄油地中海饮食组 5 年体重变化的调整差异为-0.43kg（95%CI-0.86 至-0.01；p=0.044），坚果组为-0.08kg（-0.50 至 0.35；p=0.730）。橄榄油地中海饮食组 5 年腰围变化的调整差异为-0.55cm（-1.16 至-0.06；p=0.048），坚果组为-0.94cm（-1.60 至-0.27；p=0.006），与对照组相比。
解释：与对照组相比，长期摄入无限制热量、富含蔬菜脂肪的地中海饮食与体重下降和中心性肥胖增加减少有关。这些结果支持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、加州核桃委员会、Borges SA 和莫雷利亚坚果。
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