About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
- Placebo soft chew
Treatment groups
Locations
1Sponsors and collaborators
Maastricht University Medical Center
Lead sponsor
Raisio Group
Collaborator
TKI Life Sciences and Health (LSH)
Collaborator