Dietary Intake in Adults From the GA2LEN Folow-up Survey
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|ClinicalTrials.gov Identifier: NCT03251157|
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment|
|Asthma Lung Function Decreased Food Allergy Allergic Sensitisation Allergic Rhinitis COPD Atopy||Other: Dietary intake of various nutrients, foods and biocompounds|
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.
|Study Type :||Observational|
|Actual Enrollment :||3500 participants|
|Official Title:||Dietary Intake, Allergy and Respiratory Diseases in European Adults From the GA2LEN Follow-up Survey|
|Actual Study Start Date :||January 1, 2007|
|Actual Primary Completion Date :||December 31, 2010|
|Actual Study Completion Date :||December 31, 2010|
- Other: Dietary intake of various nutrients, foods and biocompounds
Participants answered a self-administered FFQ, in which they reported the usual frequency of intake of a list of 250 food items
- Asthma score [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Last month ]Defined based on a positive answer to the question 'Do you have any nasal allergies or hay fever'?
- Asthma [ Time Frame: Last 12 months ]Asthma was defined as a history of ever having asthma and reporting at least one of the following symptoms in the last 12 months: wheeze or whistling in the chest, waking with chest tightness, waking with shortness of breath, and waking with an attack of coughing
- IgE sensitisation [ Time Frame: 1 day ]Serum concentrations of total IgE (geometric mean) were estimated
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251157
|United States, Maryland|
|Johns Hopkins Bloomberg School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Study Chair:||Peter GJ Burney, MD PhD||Imperial College London|