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A clinical trial to evaluate the effect of the Mediterranean diet on smokers lung function.
npj Primary Care Respiratory Medicine ( IF 3.1 ) Pub Date : 2019-11-27 , DOI: 10.1038/s41533-019-0153-7
Francisco Martín-Luján 1 , Roxana-Elena Catalin 2 , Patricia Salamanca-González 3 , Mar Sorlí-Aguilar 3 , Antoni Santigosa-Ayala 4 , Rosa Maria Valls-Zamora 5 , Núria Martín-Vergara 6 , Teresa Canela-Armengol 7 , Victoria Arija-Val 8 , Rosa Solà-Alberich 5
Affiliation  

Data on the association between lung function and some dietary patterns have been published. However, it is not yet well known if whether the Mediterranean Diet (MD) pattern can preserve or improve lung function. Our purpose is to evaluate the effect of increased MD adherence on lung function in smokers. A multicenter, parallel, cluster-randomized, controlled clinical trial is proposed. A total of 566 active smokers (>10 packs-year), aged 25-75 years will be included, without previous respiratory disease and who sign an informed consent to participate. Twenty Primary Care Centres in Tarragona (Spain) will be randomly assigned to a control or an intervention group (1:1). All participants will receive advice to quit smoking, and the intervention group, a nutritional intervention (2 years) designed to increase MD adherence by: (1) annual visit to deliver personalized nutritional education, (2) annual telephone contact to reinforce the intervention, and (3) access to an online dietary blog. We will evaluate (annually for 2 years): pulmonary function by forced spirometry and MD adherence by a 14-item questionnaire and medical tests (oxidation, inflammation and consumption biomarkers). In a statistical analysis by intention-to-treat basis, with the individual smoker as unit of analysis, pulmonary function and MD adherence in both groups will be compared; logistic regression models will be applied to analyze their associations. We hope to observe an increased MD adherence that may prevent the deterioration of lung function in smokers without previous respiratory disease. This population may benefit from a dietary intervention, together with the recommendation of smoking cessation.

中文翻译:

评估地中海饮食对吸烟者肺功能的影响的一项临床试验。

关于肺功能与某些饮食模式之间关系的数据已经发表。但是,地中海饮食(MD)模式是否可以保留或改善肺功能还不是很清楚。我们的目的是评估增加MD依从性对吸烟者肺功能的影响。提出了一个多中心,平行,集群随机,受控的临床试验。总共包括566名活跃吸烟者(每年> 10包),年龄在25-75岁之间,没有先前的呼吸系统疾病,并且签署了知情同意参加。西班牙塔拉戈纳的20个初级保健中心将被随机分配到对照组或干预组(1:1)。所有参与者都将获得戒烟的建议,干预小组将通过以下方式增加营养干预(2年),以提高医师对MD的依从性:(1)年度访问以提供个性化的营养教育,(2)年度电话联系以加强干预,以及(3)访问在线饮食博客。我们将评估(每年2年):通过强制肺活量测定法检测肺功能,并通过14个项目的问卷调查和医学检查(氧化,炎症和消耗性生物标志物)对MD的依从性进行评估。在以意向性治疗为基础的统计分析中,以个体吸烟者为分析单位,将比较两组的肺功能和MD依从性;逻辑回归模型将用于分析它们的关联。我们希望观察到增加的MD依从性,可以预防没有先前呼吸系统疾病的吸烟者的肺功能恶化。该人群可能会从饮食干预中受益,
更新日期:2019-11-27
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