Using plant stanol esters to reduce asthma symptoms
Plant Stanol Esters in the Prevention of Clinical Symptoms Related to Asthma: The PLANTASTIC Trial
This study is testing if eating soft chews with plant stanol esters can help people with allergic asthma feel better by changing how their immune system works.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT03983603 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of plant stanol esters on asthma symptoms in patients diagnosed with allergic asthma. The primary goal is to determine if prolonged consumption of these esters can lead to clinical benefits by shifting the immune response away from the Th2 cell dominance typical in asthma. Participants will consume soft chews containing plant stanols or a placebo, while their immune system responses and cardiovascular risk parameters will also be evaluated. The study aims to provide insights into the mechanisms by which plant stanols may influence asthma and overall metabolic health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with stable allergic asthma who have been on prescribed medication for at least one year.
Not a fit: Patients who are currently smoking or have a significant smoking history may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a novel dietary intervention to help manage asthma symptoms and improve immune function.
How similar studies have performed: While the use of plant stanols for cholesterol management is established, this specific application for asthma is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with allergic asthma (GINA step 1-4) which is in a stable phase at the moment of inclusion (defined as no changes in asthma control and lung function in (at least) the past three months) * Have been treated with prescribed asthma medication for at least one year * Aged 18-70 years old * BMI between 20 and 35 kg/m2 * Willing to abstain from products containing plant sterols or stanols one month prior to the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands) * Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands) * Willing to keep the intake of fish oil supplements constant 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 * 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
Where this trial is running
Maastricht, Limburg
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jogchum Plat, PhD — Maastricht University Medical Center
- Study coordinator: Jogchum Plat, PhD
- Email: j.plat@maastrichtuniversity.nl
- Phone: +31433881309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.