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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

Tracking Information
First Submitted Date August 12, 2017
First Posted Date August 16, 2017
Last Update Posted Date August 16, 2017
Actual Study Start Date January 1, 2007
Actual Primary Completion Date December 31, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 15, 2017)
  • 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'?
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 15, 2017)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Dietary Intake in Adults From the GA2LEN Folow-up Survey
Official Title Dietary Intake, Allergy and Respiratory Diseases in European Adults From the GA2LEN Follow-up Survey
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.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
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.
Condition
  • Asthma
  • Lung Function Decreased
  • Food Allergy
  • Allergic Sensitisation
  • Allergic Rhinitis
  • COPD
  • Atopy
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 15, 2017)
3500
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2010
Actual Primary Completion Date December 31, 2010   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03251157
Other Study ID Numbers GA2LEN Nutrition Survey
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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)
Responsible Party Vanessa Larsen, Johns Hopkins Bloomberg School of Public Health
Study Sponsor Johns Hopkins Bloomberg School of Public Health
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
Investigators
Study Chair: Peter GJ Burney, MD PhD Imperial College London
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date August 2017