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临床试验/NCT03251157
NCT03251157已完成不适用

Dietary Intake, Allergy and Respiratory Diseases in European Adults From the GA2LEN Follow-up Survey

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,500
试验地点
1
主要终点
Asthma score

研究概览

简要总结

The Nutrition Study of the GA2LEN Follow-Survey was designed to investigate the association between usual dietary intake and allergic and respiratory outcomes in adults across Europe. Within this framework, a food frequency questionnaire (FFQ) was designed to ascertain usual dietary intake of 250 food items, which was translated into the languages of the participant centres. Information on daily intake of foods, nutrients, and flavonoids was derived.

详细描述

Within the GA2LEN Follow-up Survey, the Nutrition Survey was aimed at assessing dietary intake in adults across European countries and its association with various outcomes of allergy and respiratory health. In absence of an internationally comparable dietary questionnaire to ascertain usual dietary intake, a single and standardized food frequency questionnaire (FFQ) was design to be used as a common instrument in all participant countries. The FFQ is comprised of 32 food sections and 250 food items. The FFQ sections were designed following the recommendations by the EFCOSUM Group, which facilitate international comparisons of dietary intake. It also included several staple foods to capture locally representative dietary intake.

Participants reported how often they had consumed each of the foods over the previous month, using eight predefined options (rarely or never, 1-3 times per month, once, 2-4, or 5-6 times per week, once, 2-3 times per day). Standard food portion sizes were used to quantify the intake following the recommendations from the UK's Food Standards Agency. Daily intake of foods (g) were estimated and macro- and micronutrient and flavonoid intakes were derived. The GA2LEN FFQ was validated in five EU countries, namely Finland, UK, Portugal, Germany, Poland, and Greece, and demonstrated to be a good tool to assess mid-term intake of foods, specifically essential polyunsaturated fatty acids (PUFAs). The instrument has also been demonstrated to be an accurate tool to assess dietary sources of flavonoids.

Various approaches were planned to derive dietary exposures and to examine their association with respiratory and allergic outcomes. These included the use of dietary patterns derived from Principal Component Analysis (PCA), a dietary inflammatory index (DII), as well as single antioxidants, and individual food items.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged 15-75 years old, who had responded to the GA2LEN Baseline survey and who met the definition of cases or controls (as described below)

排除标准

  • Participants who did not answer the baseline survey

结局指标

主要结局

Asthma score

时间窗: Last 12 months

Five questions on symptoms in the last 12 months (breathless when wheezing, woken with tightness in chest, shortness of breath while at rest, shortness of breath after exercise, woken by shortness of breath) were used to construct an asthma symptom score on a five-point scale

Chronic rhinosinusitis (CRS)

时间窗: Last 12 weeks

defined following the EP3OS criteria, that is, the presence of at least two of the following symptoms for at least 12 weeks in the past year: (i) nasal blockage, (ii) nasal discharge, (iii) facial pain or pressure or (iv) reduction in sense of smell with at least one of the symptoms being nasal blockage or nasal discharge

Lung function

时间窗: Day

Spirometric lung function (Forced Expiratory Volume in one second (FEV1), and Forced Vital Capacity (FVC)) were measured pre- and post- administration of bronchodilator (salbutamol 200 mg). Spirometric restriction was defined by an FVC below the limit of normal, chronic obstruction by an FEV1/FVC below the limit of normal. All spirometries were checked centrally for quality. Only spirometry that met the ERS/ATS criteria was accepted

Atopy

时间窗: 1 day

Skin prick tests (SPTs) to grass pollen, grass mix, Dermatophagoides pteronyssinus, Dermatophagoides farinae, cockroach (Blatella), olive, Alternaria, dog, Artemisia, birch, cat and Parietaria were conducted. A SPT was regarded as positive where the allergen weal was \>1 mm more than the diluent control. Atopy was defined as any positive response to any of the allergens tested

Allergic rhinitis

时间窗: Last month

Defined based on a positive answer to the question 'Do you have any nasal allergies or hay fever'?

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa Larsen

Assistant Professor in Human Nutrition

Johns Hopkins Bloomberg School of Public Health

研究点 (1)

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