Observational study into the Relationship between Asthma and Nutrition in asthma sub-Groups including clinical, functional and inflammatory Endpoints

Completed

Conditions: Asthma
pulmonary disease
10006436

Registration Number: NL-OMON48410

Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

- Asthma diagnosis according to GINA guidelines
- Step 3-5 treatment (GINA guidelines)
- Aged >=18 year
- Proficient in speaking and understanding Dutch

Exclusion Criteria

- Pregnancy
- Concurrent respiratory disease (e.g. pneumonia, bronchitis, COPD)
- Pulmonary infection or asthma exacerbation in the past 4 weeks

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoint: Nutritional intake and status<br /><br>- Intake: dietary intake of macro- and micronutrients and food groups, and the<br /><br>Dietary Inflammatory Index;<br /><br>- Status: body composition (fat mass and fat-free mass), anthropometry (BMI,<br /><br>waist- and hip circumference), muscle mass (urinary creatinine excretion),<br /><br>muscle strength (handgrip strength), functional exercise capacity (6-minute<br /><br>walking test), and nutrient status (plasma vitamins, minerals, lipids).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoint: Clinical, functional and inflammatory characteristics<br /><br>of asthma<br /><br>- Clinical: asthma control (ACQ), quality of life (AQLQ), hospital admissions,<br /><br>exacerbation frequency, and use of oral corticosteroids (health care<br /><br>utilization)<br /><br>- Functional: pulmonary function (spirometry), and medication use;<br /><br>- Inflammatory: airway inflammation (FeNO, sputum mRNA, leukocytes and cell<br /><br>differential), systemic inflammation (plasma albumin, IL-6, TNF-a, CRP), innate<br /><br>immune activity (plasma leukocytes and cell differential), and atopic status<br /><br>(IgE and RAST)</p><br>