Clinical trial NCT03251157: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Function Decreased
Food Allergy
Allergic Sensitisation
Allergic Rhinitis
COPD
Atopy
Keywords: Asthma
Adults
Europe
Lung function
Allergy
Atopy
IgE
Sensitisation
Diet
Dietary patterns
Dietary antioxidants
Flavonoids
Fruits and vegetables
Food frequency questionnaire (FFQ)
Fatty acids
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: Helsinki University Central Hospital
name: Medical University of Lodz
name: Karolinska Institutet
name: University Ghent
name: University of Wuerzburg
name: Medical University of Silesia
name: University of Coimbra
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: University of Southern Denmark
name: Uppsala University
name: Umeå University
name: Charite University, Berlin, Germany
name: University of Southampton
name: Göteborg University
name: Jagiellonian University
name: Odense University Hospital
First posted: 2017-08-16
Enrollment: 3500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Asthma score
timeFrame: Last 12 months
measure: Chronic rhinosinusitis (CRS)
timeFrame: Last 12 weeks
measure: Lung function
timeFrame: Day
measure: Atopy
timeFrame: 1 day
measure: Allergic rhinitis
timeFrame: Last month
Secondary outcomes:
Other outcomes:
measure: Asthma
timeFrame: Last 12 months
measure: IgE sensitisation
timeFrame: 1 day
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Imperial College London
name: Peter GJ Burney, MD PhD
role: STUDY_CHAIR
References:
citation: Bousquet J, Burney PG, Zuberbier T, Cauwenberge PV, Akdis CA, Bindslev-Jensen C, Bonini S, Fokkens WJ, Kauffmann F, Kowalski ML, Lodrup-Carlsen K, Mullol J, Nizankowska-Mogilnicka E, Papadopoulos N, Toskala E, Wickman M, Anto J, Auvergne N, Bachert C, Bousquet PJ, Brunekreef B, Canonica GW, Carlsen KH, Gjomarkaj M, Haahtela T, Howarth P, Lenzen G, Lotvall J, Radon K, Ring J, Salapatas M, Schunemann HJ, Szczecklik A, Todo-Bom A, Valovirta E, von Mutius E, Zock JP. GA2LEN (Global Allergy and Asthma European Network) addresses the allergy and asthma 'epidemic'. Allergy. 2009 Jul;64(7):969-77. doi: 10.1111/j.1398-9995.2009.02059.x. Epub 2009 Apr 7.
citation: Garcia-Larsen V, Arthur R, Potts JF, Howarth PH, Ahlstrom M, Haahtela T, Loureiro C, Bom AT, Brozek G, Makowska J, Kowalski ML, Thilsing T, Keil T, Matricardi PM, Toren K, van Zele T, Bachert C, Rymarczyk B, Janson C, Forsberg B, Nizankowska-Mogilnicka E, Burney PGJ. Is fruit and vegetable intake associated with asthma or chronic rhino-sinusitis in European adults? Results from the Global Allergy and Asthma Network of Excellence (GA2LEN) Survey. Clin Transl Allergy. 2017 Jan 27;7:3. doi: 10.1186/s13601-016-0140-9. eCollection 2017.
citation: Garcia-Larsen V, Luczynska M, Kowalski ML, Voutilainen H, Ahlstrom M, Haahtela T, Toskala E, Bockelbrink A, Lee HH, Vassilopoulou E, Papadopoulos NG, Ramalho R, Moreira A, Delgado L, Castel-Branco MG, Calder PC, Childs CE, Bakolis I, Hooper R, Burney PG; GA2LEN-WP 1.2 'Epidemiological and Clinical Studies'. Use of a common food frequency questionnaire (FFQ) to assess dietary patterns and their relation to allergy and asthma in Europe: pilot study of the GA2LEN FFQ. Eur J Clin Nutr. 2011 Jun;65(6):750-6. doi: 10.1038/ejcn.2011.15. Epub 2011 Mar 23.