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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
Sponsor:
Collaborators:
Imperial College London
Helsinki University Central Hospital
Medical Universtity of Lodz
Karolinska Institutet
University Ghent
University of Wuerzburg
Medical University of Silesia
University of Coimbra
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Southern Denmark
Uppsala University
Umeå University
Charite University, Berlin, Germany
University of Southampton
Göteborg University
Jagiellonian University
Odense University Hospital
Information provided by (Responsible Party):
Vanessa Larsen, Johns Hopkins Bloomberg School of Public Health

Brief Summary:
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.

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

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 3500 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Allergic rhinitis [ Time Frame: Last month ]
    Defined based on a positive answer to the question 'Do you have any nasal allergies or hay fever'?


Other Outcome Measures:
  1. 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

  2. IgE sensitisation [ Time Frame: 1 day ]
    Serum concentrations of total IgE (geometric mean) were estimated


Biospecimen Retention:   Samples Without DNA
Participants had serum taken which was stored frozen and subsequently analysed in a central laboratory to estimate concentration of several biomarkers including hormones (e.g. leptin), markers of inflammation (cytokines CRP, Interleukin 6 (IL-6), Interleukin 8 (IL-8), Tumour Necrosis Factor alpha (TNF-α) Transforming Growth Factor beta (TGF-β) and Myeloperoxidase (MPO)), and serum levels of total and allergen-specific IgEs.


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The GA2LEN follow-up study was a multi-center case-control study with participants selected from the respondents to an initial cross-sectional survey of a general population of adults aged 15-74 years living in 17 European cities and completed between June 2007 and May 2009. A random sample of eligible participants who indicated a willingness to be re-contacted was selected based on their responses to the initial postal survey. The cases were participants who either had asthma, sinusitis or both and the controls (who lived in the same areas) were those who reported having neither. Each center recruited up to 120 cases each of patients with asthma only, CRS only, controls and 40 patients with both asthma and CRS based on the responses to the initial cross-sectional survey.
Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Participants who did not answer the baseline survey


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251157


Locations
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United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Imperial College London
Helsinki University Central Hospital
Medical Universtity of Lodz
Karolinska Institutet
University Ghent
University of Wuerzburg
Medical University of Silesia
University of Coimbra
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Southern Denmark
Uppsala University
Umeå University
Charite University, Berlin, Germany
University of Southampton
Göteborg University
Jagiellonian University
Odense University Hospital
Investigators
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Study Chair: Peter GJ Burney, MD PhD Imperial College London

Publications:

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Responsible Party: Vanessa Larsen, Assistant Professor in Human Nutrition, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03251157     History of Changes
Other Study ID Numbers: GA2LEN Nutrition Survey
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Queries on IPD from the GA2LEN Nutrition Survey may be sent to the study Principal Investigator Dr Vanessa Garcia Larsen (vgla@jhu.edu) or to the study Chair Professor Peter GJ Burney (p.burney@imperial.ac.uk)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vanessa Larsen, Johns Hopkins Bloomberg School of Public Health:
Asthma
Adults
Europe
Lung function
Allergy
Atopy
IgE
Sensitisation
Diet
Dietary patterns
Dietary antioxidants
Flavonoids
Fruits and vegetables
Food frequency questionnaire (FFQ)
Fatty acids

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Insufficiency
Hypersensitivity
Food Hypersensitivity
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiration Disorders
Nutrients
Growth Substances
Physiological Effects of Drugs