NCT03983603Recruiting
Plant Stanol Esters and Preventing Asthma Symptoms
The Effects of Long-term Daily Plant Stanol Ester Intake on Clinical Symptoms in Individuals With Allergic Asthma: an Exploratory Double-blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
Plant stanols are known to lower low-density lipoprotein cholesterol. However, studies have suggested that these compounds also influence the immune system. Asthmatic responses are predominantly T helper (Th)2 cell dependent, while plant stanols were previously found to activate Th1 cells and shift the immune response away from the Th2 cell dominant asthmatic response. The question now is whether this also translates into a reduction of clinical symptoms in asthma patients.The primary objective of this study is to demonstrate clinical benefits of prolonged consumption of plant stanols (delivered via plant stanol esters) in asthma patients. The secondary objectives are to evaluate the mechanisms via which plant stanols modulate the immune system and to evaluate the effects of plant stanol ester consumption on cardiovascular (CVD) risk parameters.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 4 Jun 2019
- Start date
- 29 Apr 2019
- Primary completion date
- Sept 2026
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Asthma
- NCT number
- NCT03983603
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 29 Apr 2019 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having donated blood within one month prior to the start of the study, or planning to donate blood during the study
Other illness
- 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)
Lab values
- Fasting plasma glucose \> 7.0 mmol/L
- Fasting serum TC \> 8.0 mmol/L
Other
- 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)
- Pregnant women
- Breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.