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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56238
Enrollment
300
Registered
2019-02-18
Start date
2019-04-29
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic asthma asthma

Interventions

The intervention group will receive soft chews containing 0.5g plant stanols each (present as plant stanol esters) and are required to take six chews daily (two after each main meal) in order to rea

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the change in asthma control questionnaire (ACQ) score from baseline to the end of the study.

Secondary

MeasureTime frame
Secondary endpoints include lung function parameters, markers for immune function, medication use, CVD risk parameters and vaccination response.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)