Dietary Intake in Adults From the GA2LEN Folow-up Survey

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251157
• Other study ID #: GA2LEN Nutrition Survey
• Status: Completed
• Phase: N/A
• First received: August 12, 2017
• Last updated: August 15, 2017
• Start date: January 1, 2007
• Est. completion date: December 31, 2010

Study information

• Verified date: August 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: December 31, 2010
• Est. primary completion date: December 31, 2010
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergic Sensitisation
• Asthma
• Atopy
• COPD
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Lung Function Decreased
• Rhinitis
• Rhinitis, Allergic

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

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (18)

Lead Sponsor

Collaborator

Johns Hopkins Bloomberg School of Public Health

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Charite University, Berlin, Germany, Göteborg University, Helsinki University Central Hospital, Imperial College London, Jagiellonian University, Karolinska Institutet, Medical University of Silesia, Medical Universtity of Lodz, Odense University Hospital, Umeå University, University Ghent, University of Coimbra, University of Southampton, University of Southern Denmark, University of Wuerzburg, Uppsala University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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, Schünemann 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. — View Citation

Garcia-Larsen V, Arthur R, Potts JF, Howarth PH, Ahlström M, Haahtela T, Loureiro C, Bom AT, Brozek G, Makowska J, Kowalski ML, Thilsing T, Keil T, Matricardi PM, Torén 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 (GA(2)LEN) Survey. Clin Transl Allergy. 2017 Jan 27;7:3. doi: 10.1186/s13601-016-0140-9. eCollection 2017. — View Citation

Garcia-Larsen V, Luczynska M, Kowalski ML, Voutilainen H, Ahlström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Asthma	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	Last 12 months
Other	IgE sensitisation	Serum concentrations of total IgE (geometric mean) were estimated	1 day
Primary	Asthma score	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	Last 12 months
Primary	Chronic rhinosinusitis (CRS)	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	Last 12 weeks
Primary	Lung function	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	Day
Primary	Atopy	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	1 day
Primary	Allergic rhinitis	Defined based on a positive answer to the question 'Do you have any nasal allergies or hay fever'?	Last month