Plant stanol esters in the prevention of clinical symptoms related to asthma: the PLANTASTIC trial

Recruiting

Conditions: allergic asthma
asthma
10001708
10013317
10024967

Registration Number: NL-OMON56238

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

- Having allergic asthma (step 1-4 according to GINA 2019 guidelines), stable
at the moment of inclusion
- Have been treated with low or medium dose inhalation corticosteroids in
combination with a SABA or LABA, or as-needed low dose ICS-formoterol, or
appropriate alternative medication according to the GINA guidelines for at
least one year
- Aged 18-70
- BMI between 20 and 35 kg/m2
- Willing to abstain from products containing plant sterols and/or stanols one
month before and during the study
- Willing to keep the intake of fish oil supplements constant during the study

Exclusion Criteria

- Currently smoking or quitted smoking in the past year, with a maximum of 10
packyears as smoking history (packyears = packs per day * years of smoking)
- Allergy to an ingredient of the soft chews
- Treatment with HMG-CoA reductase inhibitors (statins) to lower serum
cholesterol
- Suffering from inflammatory diseases (for CVD, illness must be minimally 3
years ago and currently under control in order to participate in the study)
- Fasting plasma glucose > 7.0 mmol/L
- Fasting serum TC > 8.0 mmol/L
- Having donated blood within one month prior to the start of the study, or
planning to donate blood during the study
- Pregnant women
- Breastfeeding women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the change in asthma control questionnaire (ACQ)<br /><br>score from baseline to the end of the study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include lung function parameters, markers for immune<br /><br>function, medication use, CVD risk parameters and vaccination response.</p><br>